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"FUTURE GP DRUGS ON THE HORIZON"
June 23, 2009-Tranzyme Pharma CEO Vipin Garg WINS Ernst & Young Entrepreneur Of The Year® 2009 Award
RTP, NC (June 23, 2009) – Tranzyme
Pharma, a clinical stage biotechnology company, today announced that its President and CEO, Vipin K. Garg, PhD, received the
Ernst & Young Entrepreneur Of The Year® 2009 Award in the health
sciences category for the Carolinas Region. According to Ernst & Young LLP, the award recognizes outstanding entrepreneurs
who demonstrate extraordinary success in the areas of innovation, financial performance and personal commitment to their businesses
and communities. Dr. Garg was selected by an independent panel of judges and the award was presented at a celebration banquet
at the Westin Charlotte on June 18, 2009.
The program has expanded
to recognize business leaders in over 135 cities in 50 countries throughout the world.
“I
am grateful for Ernst & Young’s continued dedication and commitment to supporting and recognizing entrepreneurs
worldwide and I want to thank all of the sponsors of this year’s magnificent event”, said Garg. “I am honored
to receive this most prestigious recognition and graciously accept it on behalf of my Tranzyme colleagues and our supportive
investors and board members, as it is indeed a reflection of our collective efforts.”
As
a regional award winner, Dr. Garg is eligible for consideration for the Ernst & Young LLP Entrepreneur Of The Year national
program. Award winners in several national categories, as well as the overall national Ernst & Young Entrepreneur Of The
Year award winner, will be announced at the annual awards gala in Palm Springs, California on November 14, 2009. The awards
are the culminating event of the Ernst & Young Strategic Growth Forum, the nation’s most prestigious gathering of
high-growth, market-leading companies.
Sponsors
Founded and produced by Ernst & Young LLP, the Entrepreneur Of The Year awards are pleased to
have the Ewing Marion Kauffman Foundation and SAP America as national sponsors.
In the Carolinas, sponsors included King & Spalding, Bowne and Business Leader Media.
About
Ernst & Young’s Entrepreneur Of The Year® Awards Program
Ernst & Young’s Entrepreneur Of The Year® Award is the world’s
most prestigious business award for entrepreneurs. The award makes a difference through the way it encourages entrepreneurial
activity among those with potential and recognizes the contribution of people who inspire others with their vision, leadership
and achievement. As the first and only truly global award of its kind, the Ernst & Young Entrepreneur Of The Year® award
celebrates those who are building and leading successful, growing and dynamic businesses, recognizing them through regional,
national and global awards programs in more than 135 cities in 50 countries.
About Tranzyme Pharma
Tranzyme
Pharma is a clinical stage biotechnology company engaged in the discovery and development of first-in-class small molecule
therapeutics for the treatment of both acute care (hospital-based) and chronic indications with significant unmet medical
needs.
May 5, 2009-Tranzyme Pharma Initiates Dosing in a Phase 2 Study of its Oral Ghrelin Agonist
TZP-102 in Patients with Gastroparesis
RESEARCH TRIANGLE PARK, N.C. (May 5, 2009) – Tranzyme Pharma today announced that it has initiated dosing in a Phase 2 study of TZP-102,
its potent and selective second generation oral ghrelin agonist, in diabetic patients with gastroparesis. Gastroparesis
is an inability of the stomach to empty food efficiently, and comprises a prevalent and serious complication of diabetes mellitus.
The characteristics of the compound allow for chronic administration in an out-patient setting.
This Phase 2, randomized, double-blind, placebo-controlled study to be conducted at multiple sites in the US and Europe, will evaluate
the safety and efficacy of three 28-day, once-daily, dosage regimens of TZP-102 (10, 20 & 40 mg) in accelerating gastric
emptying and improving symptoms of gastroparesis among 80 patients with diabetic gastroparesis.
“Initiating this study of TZP-102, our second novel, internally discovered compound, is another important milestone
for Tranzyme. This follows on the recent completion of two successful Phase 2 trials of our lead product TZP-101 (ghrelin
agonist for IV administration) for the treatment of gastroparesis in acute settings and postoperative ileus (POI),”
commented Vipin K. Garg, PhD, President and CEO of Tranzyme. “We remain committed to finding new and safe therapeutics
for critical, unmet medical needs.”
About
TZP-102
TZP-102 is a novel, orally administered prokinetic agent that acts by a mechanism distinct from previously developed
products for gastrointestinal (GI) motility disorders. TZP-102 is a second generation agonist of the ghrelin receptor (which
is distributed in both the upper and lower GI tract). TZP-102 has the potential to treat gastroparesis and other chronic
GI and motility disorders, including GERD, functional dyspepsia, opioid bowel dysfunction and irritable bowel syndrome with
constipation. TZP-102 originated from Tranzyme’s proprietary MATCH™ drug discovery technology.
Tranzyme Pharma’s Successful Phase 2 Postoperative
Ileus Trial Results to be Presented at the American Society of Colon and Rectal Surgeons 2009 Annual Meeting
RESEARCH TRIANGLE PARK, N.C. (May 4, 2009) – Tranzyme Pharma today
announced that Anthony J. Senagore, MD, MBA, MS, FACS, Vice President, Research & Education of Spectrum Health and Professor
of Surgery, Michigan State University/CHM, will present results from the successful study of ghrelin agonist TZP-101 for the
management of postoperative ileus (POI) at the upcoming 2009 Annual Meeting of the American Society of Colon and Rectal Surgeons
(ASCRS) being held from May 2-6, 2009. Dr. Senagore’s presentation will take place on Wednesday, May 6, 2009 at 4:50
p.m. EST in the Atlantic Ballroom of the Westin Diplomat Hotel in Hollywood, FL.
POI is a transient impairment of gastrointestinal (GI) function following abdominal or other surgery and
is often protracted and exacerbated by multiple factors including the use of opioids for pain management. Symptoms include
abdominal distention, pain, nausea and vomiting, and inability to pass stools and tolerate a solid diet. Delays in resuming
a normal diet may lead to poor wound healing and increased risk of infection through a cascade of events. POI is associated
with an increased length of hospital stay and is the most common cause of delayed hospital discharge after abdominal surgery.
The prolonged hospitalization raises the possibility for serious pulmonary complications. In the United States alone, 2.4
million patients undergo open abdominal surgery each year and are at high risk for POI (Source: Premier Database). No unrestricted
treatments for POI have been approved by the US Food and Drug Administration to date.
Tranzyme is planning a Phase 3 trial with TZP-101 for POI with the primary efficacy endpoint of “GI2”
- the time to GI function recovery as defined by the later of first bowel movement (BM) and first solid food intake. The Phase
2 study (which enrolled ~250 patients undergoing partial large bowel resection) demonstrated TZP-101’s ability to reduce
the time to GI2 by 23.3 hours over placebo (PBO), and that difference is clinically and statistically significant (p<0.05).
Another clinically important endpoint, the proportion of patients who had early recovery of GI function (within 72 hours)
indicated a marked increase on TZP-101 (65% of patients) over placebo (25% of patients). The observed difference was evidently
significant (p=0.004). The most typical adverse events for the post-surgical population, nausea and vomiting, were noticeably
decreased in the TZP-101 group as compared to placebo. In the placebo group, nausea and vomiting were reported for 27%
and 16% patients, respectively. In contrast, for the two most effective study doses, fewer than 5% of TZP-101 patients experienced
nausea or vomiting, consistent with the strong GI prokinetic activity of TZP-101 and the early GI recovery.
April 22, 2009-Tranzyme Pharma Announces Positive Phase 2 Results with TZP-101 for Improvement of Symptoms in Patients
with Gastroparesis
RESEARCH TRIANGLE PARK, N.C. (April 22, 2009) – Tranzyme Pharma today announced
that
its first-in-class, potent and selective ghrelin agonist, TZP-101,
demonstrated effectiveness in the treatment of gastroparesis,
an inability of
the stomach to empty food efficiently, especially in patients with diabetes
mellitus (DM). Clinical
trial results indicated that TZP-101 was safe and highly
effective in improving multiple symptoms associated with gastroparesis.
A
total of 76 patients with either type 1 or type 2 DM and a confirmed diagnosis
of gastroparesis (by presence of both chronic
symptoms and objective
demonstration of delayed gastric emptying) were enrolled in a US and EU,
double-blind, placebo-controlled
Phase 2 trial designed to evaluate the safety
and efficacy of TZP-101. Patients were voluntarily admitted to the hospital
and
adaptively randomized to receive a daily 30-min IV infusion of one of six doses
of TZP-101 (20-600ìg/kg) or placebo
for 4 consecutive days. Overall, 57 subjects
received TZP-101 and 19 received placebo. Patient safety was monitored by
vital
signs, ECGs, physical exams, clinical chemistry and adverse events.
During treatment and at a 30-day follow-up
visit, efficacy was evaluated by
symptom improvement as assessed by both the patients and the investigators. The
Gastroparesis
Cardinal Symptom Index (GCSI), a questionnaire for assessing the
severity of symptoms associated with gastroparesis, was
administered to each
subject prior to dosing, on each of the treatment days and at the follow-up
visit. Additionally,
meal-related Gastroparesis Symptom Assessment (GSA) and
Clinician Rated Symptom Assessment (CRSA) scores were collected
for the study.
Summary Results: 80ìg/kg was determined to be the TZP-101 dose which achieved
maximum clinical benefit.
Upon completion of the 4-day dosing period,
improvement in symptoms in TZP-101-treated subjects was statistically
significant
(or trending toward significance) over placebo-treated subjects as
determined by one or more of the evaluation tools (GCSI,
GSA, CRSA) for the
following symptoms: vomiting (p=0.006), loss of appetite (p=0.034), postprandial
fullness (p=0.007),
early satiety (p=0.087), abdominal distension (p=0.053) and
bloating (p=0.0822). Statistical significance was also observed
by the CRSA
Overall Symptom scores (p=0.046). The 30-day follow-up evaluation demonstrated a
sustained benefit in symptom
improvement in the TZP-101 group. This effect
reached statistical significance (p=0.023) for vomiting, a particularly
debilitating
complication of gastroparesis. In addition, proportionally fewer
subjects (3%) in the TZP-101 group required hospitalization
for gastroparesis
during the 30-day follow-up period versus the placebo group (10%). TZP-101 was
safe and well-tolerated
at all doses tested.
"We are encouraged to see that TZP-101, given intravenously for only 4 days,
induced an acute
and sustained reduction of symptoms offering a potential new
therapy for patients with gastroparesis and other GI motility
disorders in acute
settings," said Gordana Kosutic, MD, Vice President, Clinical and Regulatory
Affairs for Tranzyme.
"These results are consistent with the potent prokinetic
properties of TZP-101 and complement our previously reported successful
Phase 2
study with TZP-101 for the management of postoperative ileus (POI)."
"We recognize the severity of symptoms
caused by gastroparesis and their impact
on quality of life, and are anxious to bring relief to the millions of patients
suffering
from this condition. We now plan to initiate a Phase 3 program to
further evaluate the efficacy and safety of TZP-101 in
this patient population,"
stated Vipin K. Garg, PhD, President and CEO of Tranzyme.
March 11, 2009-Tranzyme Pharma Announces Issuance of Three New Patents Further Strengthening
Company’s Advanced Ghrelin Agonist Programs
RESEARCH TRIANGLE PARK, N.C. (March 11, 2009) - Tranzyme Pharma, a late stage biopharmaceutical
company engaged in the discovery and development of first-in-class small molecule therapeutics, announced today that the U.S.
Patent and Trademark Office (USPTO) has issued three patents further enhancing Tranzyme’s intellectual property portfolio
for its current and future drug candidates. They are:
§ US 7,476,653: Macrocyclic modulators of the ghrelin receptor
§ US 7,491,695: Methods of using macrocyclic modulators of the ghrelin receptor
§ US 7,452,862: Conformationally-controlled biologically active macrocyclic
small molecules as motilin antagonists or ghrelin agonists
Combined, these patents, with terms until at least 2024, provide strong and broad protection for the chemical
structural class comprising Tranzyme’s lead pharmaceutical development programs. Further, they provide Tranzyme with
specific protection for the therapeutic uses of its ghrelin agonists in the treatment of gastrointestinal (GI) motility disorders,
and for the composition-of-matter of the Company’s most advanced drug candidate, TZP‑101. TZP-101 is an intravenous
ghrelin agonist ready to enter Phase 3 studies for the management of postoperative ileus (POI).
In addition, these patents expand coverage around the Company’s proven drug discovery
technology, Macrocyclic Template Chemistry (MATCH™), from which Tranzyme’s entire pipeline of novel therapeutics
is derived.
“The validation by the USPTO of the novelty of TZP-101 and its uses is another significant
milestone in bringing new therapeutic options to market for the treatment of serious and costly unmet medical needs,”
said Vipin K. Garg, PhD, Tranzyme’s President and CEO. “We expect this drug will become the first-line option
for the treatment of POI, a condition for which nearly 1 million open surgical patients are at risk in the U.S. each year,
as well as for other indications in acute settings where an intravenous prokinetic drug is required.”
"These patent issuances reflect our strategy to construct a broad and robust IP portfolio
to protect each of our pharmaceutical development programs as well as the underlying technology," stated Mark L. Peterson,
PhD, Vice President, Intellectual Property & Operations, for Tranzyme Pharma.
About Postoperative Ileus
Postoperative ileus is a transient impairment of GI motility following abdominal or other
surgery with symptoms which can include abdominal distention, pain, nausea and vomiting, and inability to pass stools and
tolerate a solid diet. Delays in resuming a normal diet may lead to poor healing and patients are at greater risk for pulmonary
complications since POI may result in reduced patient mobility. POI is associated with an increased length of hospital stay
and is the most common cause of delayed hospital discharge after abdominal surgery. In the United States alone, nearly 1 million
people undergo high risk open surgery each year (Source: Premier Database). No unrestricted treatments for POI have been approved
by the U.S. Food and Drug Administration to date.
About TZP-101
TZP-101, Tranzyme’s intravenous ghrelin agonist, is the first product from the Company’s
internal drug discovery efforts. TZP-101 is being evaluated clinically for the treatment of POI and gastroparesis in acute
care settings and has the potential to address other indications requiring administration of intravenous prokinetic agents.
In addition to the recent successful POI Phase 2b trial, an additional Phase 2b trial for the management of gastroparesis
is nearing completion. The safety and pharmacokinetic profiles of TZP-101 have been extensively characterized in healthy subjects
across multiple dose levels, and the GI prokinetic properties of the compound have been well established in humans and various
animal models, with or without concomitant opioids. In addition to TZP-101, Tranzyme is developing an oral ghrelin agonist,
TZP-102, for the out-patient treatment of gastroparesis and other chronic GI motility disorders, including GERD and functional
dyspepsia. TZP-102 will enter Phase 2 trials later this year.
March 3, 2009-'EVOKE PHARMA DEVELOPING ITS DIABETIC GASTROPARESIS DRUG IN STEALTH MODE'
San Diego-based Evoke Pharma has managed to maintain a low profile since early 2007, when the specialized drug
development company got started with the help of some prominent names in the local biotech industry.
Cam Garner, who is listed on Evoke’s web site as a co-founder and chairman, has been on the ground floor of Cadence Pharmaceuticals and at least six other San Diego life
sciences startups. Ken Widder, who has founded seven biomedical companies, including NovaCardia and Santarus, also is identified
as an Evoke board member.
So when a brief surfaced recently about Evoke getting some new venture funding, I called CFO Matt D’Onofrio to clarify the terms and to learn a little
more about Evoke and how it got started. D’Onofrio took my call, but he declined to discuss the deal, saying Evoke prefers
to remain in stealth mode at this time. He told me all that Evoke is saying is what’s available on the company’s
web site.
As limited as it is, the information is pretty interesting. A lone Evoke Pharma press release, which was dated June 15, indicates the company was headed at that time for a late-stage clinical trial of a new drug candidate
for treating a particular gastrointestinal disorder known as diabetic gastroparesis. Evoke elsewhere describes gastroparesis
generally as a common problem affecting some 8 million Americans in which the stomach is unable to contract normally, and
therefore cannot crush food or push it into the small intestine properly. The symptoms include vomiting, bloating and pain.
Evoke says diabetes is a major cause of gastroparesis, accounting for almost one-third of all cases, although
the specific mechanism is unknown. After announcing the successful completion of an early stage trial in its June press release,
Evoke said it was planning to discuss its results and a late-stage clinical trial strategy with the FDA in October, with an
eye toward starting final-stage trials in 2009.
That’s about the extent of the information available from Evoke’s web site, and the company issued
no follow-up announcement in the fall. So perhaps that’s when CEO Dave Gonyer and the board decided it was time to slip
below the radar. In fact, they had never really called attention to the company in the first place.
Nevertheless, some additional information is available from an amended disclosure form concerning Evoke’s
venture investors, which the company filed with state officials in December. The paperwork shows Evoke has raised a total
of almost $12.3 million in equity investments since the company was founded two years ago, although it doesn’t reveal
how many tranches it has taken. The investors include Domain Associates, a venture capital firm in Princeton, NJ, that is
among San Diego’s most-active life sciences investors, Latterell Venture Partners of San Francisco and individual investors.
Even if Evoke won’t discuss how they’re using the venture funding, it’s nice to know that
some local biotechs are still getting funded.
Phase 2 Development For The Treatment Of Gastroparesis
RESEARCH TRIANGLE PARK, N.C. (January 6, 2009) Tranzyme Pharma, a clinical stage
biopharmaceutical company engaged in the discovery and development of first-in-class small molecule therapeutics, announced
today that Vipin K. Garg, Ph.D., President and CEO, will present at the upcoming 27th Annual JP Morgan Healthcare Conference
being held from January 12-15, 2009. Tranzyme’s presentation will take place on Monday, January 12, 2009 at 8:30 a.m.
PST at the Westin St. Francis Hotel in San Francisco, CA.
Dr. Garg will provide a corporate and product overview as well as a summary of positive
clinical results for the company’s first-in-class, highly potent and selective ghrelin agonists, TZP-101 and TZP-102.
During Q1 2009, TZP-101 is scheduled to enter a Phase 3 trial for the management of postoperative ileus (POI), and TZP-102
will enter into Phase 2 development for the treatment of gastroparesis.
About Tranzyme Pharma
Tranzyme Pharma is engaged in the discovery and development of breakthrough small molecule
therapeutics for the treatment of both acute care (hospital-based) and chronic indications with significant unmet medical
needs. In addition to TZP-101 and TZP-102, the company is developing a ghrelin antagonist, TZP-301, for the treatment of obesity
and metabolic syndrome, and a motilin antagonist, TZP-201 for the treatment of various forms of moderate-to-severe diarrhea.
Tranzyme has developed a pipeline of novel drugs through its proprietary MATCH™
drug discovery technology which accelerates the progression of compounds from discovery to commercial track by generating
small molecule drug candidates that display the favorable characteristics exhibited by large biomolecules, such as tight receptor
binding for high potency and exquisite target selectivity, while maintaining the benefits typically associated with small
molecule drugs including oral bioavailability, cost of synthesis, and ease of formulation.
Tranzyme Pharma Announces
Positive Phase IIb Results with Its Ghrelin Agonist, TZP-101, for Postoperative Ileus (POI)
Phase
III Initiation Targeted Q1 2009
RESEARCH TRIANGLE PARK, N.C. (October 1, 2008) - Tranzyme Pharma today announced positive Phase IIb results
for its first-in-class, highly potent and selective ghrelin agonist, TZP-101, for the management of postoperative ileus (POI).
Results demonstrated that TZP-101 was both safe and highly effective in reducing the duration of ileus following surgery in
patients undergoing open bowel resection.
Over 200 patients were enrolled in an
adaptive, multinational, double-blind, placebo-controlled Phase IIb clinical trial designed to assess the time to recovery
of gastrointestinal (GI) function. Either TZP-101 or placebo was administered intravenously within the first hour after surgery,
followed by once-daily dosing for up to seven days. The primary study endpoint was time to first bowel movement (BM), also
known as “GI1”. Given its pharmacoeconomic importance, a key secondary endpoint was the percentage of patients
that achieved GI recovery within 72 hours of surgery.
For the primary endpoint, TZP-101 was superior to placebo at all doses tested. For the two
most effective doses, 80µg/kg and 480µg/kg, Cox proportional hazard ratios were 1.57; P=0.056, and 1.67; P=0.029 respectively.
After accounting for covariates, including country, type of surgery, age and opioid consumption, the dose and drug effect
for the primary endpoint persisted. In the Kaplan-Meier “GI1” analysis, median times to first BM were 70.5 and
68.0 hours for the 80µg/kg and 480µg/kg dose groups, respectively, versus 89.6 hours for placebo. Further, nearly 2/3
(64%) of patients in both the 80µg/kg and 480µg/kg dose groups had a BM within 72 hours, versus only 25% in placebo; (P=0.001
for both dose groups).
Statistical significance was also achieved in another important
secondary endpoint, time to recovery of GI function as defined by the later of the first BM and first solid food intake, referred
to as “GI2”. In the Kaplan-Meier analysis, median times for the “GI2” endpoint were identical to “GI1”,
70.5 and 68.0 hours for the 80µg/kg and 480µg/kg groups, respectively, versus 91.3 hours for placebo. The “GI2”
Cox proportional hazard ratio for 80µg/kg=1.65; P=0.034 and for 480µg/kg=1.61; P=0.044.
In June, the Company completed a “Thorough QT/QTc” study
of TZP-101 with no adverse signals identified. In the current Phase IIb study, TZP-101 was well tolerated without any identified
safety concerns. As expected, the most frequently observed adverse events in this post-surgical population were nausea (26.5%)
and vomiting (16.1%) in the placebo group. In contrast, for the two most effective study doses, fewer than 5% of TZP-101
patients experienced nausea or vomiting, consistent with the strong GI prokinetic activity of TZP-101.
“The ability of TZP-101 to increase the percentage of patients
achieving recovery within 72 hours is particularly impressive and represents a major advancement in the management of postoperative
ileus, a condition which carries significant associated morbidity and costs,” stated Anthony Senagore, MD, MBA. Dr.
Senagore, a TZP-101 study investigator, is Professor of Surgery, Michigan State University College of Human Medicine, and
Vice President of Research and Medical Education for Spectrum Health.
“We are extremely pleased with the outcome of this study and
look forward to advancing TZP-101 into a Phase III trial early next year,” said Gordana Kosutic, MD, the Company’s
VP, Clinical and Regulatory Affairs.
About Postoperative Ileus
Postoperative ileus is a transient impairment of GI motility following
abdominal or other surgery and is often protracted and exacerbated by multiple factors including the use of opioids for pain
management. Symptoms of POI can include abdominal distention, pain, nausea and vomiting, and inability to pass stools and
tolerate a solid diet. Delays in resuming a normal diet may lead to poor healing and increased risk of infection through a
cascade of events, and patients are at greater risk for pulmonary complications since POI may result in reduced patient mobility.
POI is associated with an increased length of hospital stay and is the most common cause of delayed hospital discharge after
abdominal surgery. In the United States alone, 2.4 million patients undergo open abdominal surgery each year and are at high
risk for POI (Source: Premier Database). No unrestricted treatments for POI have been approved by the US Food and Drug Administration
to date.
About TZP-101
TZP-101, Tranzyme’s intravenous ghrelin agonist, is a product
of the Company’s internal drug discovery efforts. TZP-101 is being evaluated clinically for use in acute care settings,
including POI and gastroparesis. In addition to the recently completed POI trial, a Phase IIb gastroparesis trial is nearing
completion. The safety and pharmacokinetic profiles of TZP-101 have been extensively characterized in healthy subjects across
multiple dose levels, and the prokinetic properties of the compound have been well established in various animal models, with
or without concomitant opioids. In addition to TZP-101, Tranzyme is developing an oral ghrelin agonist, TZP-102, for the out-patient
treatment of gastroparesis and other chronic GI motility disorders, such as GERD and functional dyspepsia.
Tranzyme Pharma Receives Notices of Allowance from USPTO on
Two Patents Protecting Company’s Lead Pharmaceutical Development Programs
RESEARCH TRIANGLE PARK, N.C.
(July 22, 2008) - Tranzyme Pharma, a leading biopharmaceutical company developing novel mechanism-based therapeutics for the
treatment of gastrointestinal (GI) and metabolic disorders, announced today that the Company has received Notices of Allowance
from the U.S. Patent and Trademark Office (USPTO) for two patent applications entitled “Macrocyclic Modulators of the
Ghrelin Receptor” and “Spatially-Defined Macrocyclic Compounds Useful for Drug Discovery”.
Together,
the patents expected to be issued based on these notices of allowance, with anticipated terms until 2025 and 2024, respectively,
would provide strong and broad protection for the chemical structural class comprising Tranzyme’s primary pharmaceutical
development programs, including the composition-of-matter of TZP-101, the Company’s leading drug candidate. TZP-101
is an intravenous ghrelin agonist that Tranzyme is evaluating in two concurrent Phase IIb trials for the treatment of postoperative
ileus (POI) and gastroparesis. In addition, these patents will expand coverage around the Company’s proven drug discovery
technology, Macrocyclic Template Chemistry (MATCH™), from which Tranzyme has developed its pipeline of first-in-class therapeutics.
“These Notices
of Allowance represent a significant milestone for the Company as they will lead to the first patents related directly to
our pharmaceutical development programs and affirm the uniqueness and patentability of our macrocyclic structures,”
stated Mark L. Peterson, PhD, Vice President, Intellectual Property & Operations, for Tranzyme Pharma.
About Postoperative
Ileus
Postoperative ileus is a transient impairment of GI motility following abdominal or other surgery with symptoms which
can include abdominal distention, pain, nausea and vomiting, and inability to pass stools and tolerate a solid diet. Delays
in resuming a normal diet may lead to poor healing through a cascade of events, and patients are at greater risk for pulmonary
complications since POI may result in reduced patient mobility. POI is associated with an increased length of hospital stay
and is the most common cause of delayed hospital discharge after abdominal surgery. In the United States alone, it is estimated
that 22 million patients undergo surgical procedures requiring pain management and of these patients, 2.4 million undergo
high risk open surgery each year (Source: Premier Database). No unrestricted treatments for POI have been approved by the
US Food and Drug Administration to date.
About Gastroparesis
Gastroparesis is an impairment or paralysis of upper
gastrointestinal tract function characterized by delayed gastric emptying in the absence of mechanical obstruction. Symptoms
of gastroparesis include post-prandial fullness, early satiety, abdominal pain, nausea, vomiting and weight loss. Disease
severity ranges from mild to severe. Gastroparesis is a major complication of diabetes leading to metabolic imbalance when
liquid and food intake and absorption of oral medications is impaired. Gastroparesis may also result from abdominal surgery
or be idiopathic in nature. Current medications for the treatment of gastroparesis are only moderately effective and many
are associated with adverse neurological side effects. It is estimated that approximately 5 million patients suffer from gastroparesis
in the United States.
June 23, 2008-Tranzyme Pharma Announces SuccessfulThorough
QT/QTc Study of Ghrelin Agonist TZP-101
Tranzyme
Pharma announces the successful results from a “Thorough QT/QTc” study of the company’s lead product TZP-101,
an intravenous gastrointestinal prokinetic agent currently in two Phase IIb trials for the treatment of postoperative ileus(POI)
and severe gastroparesis.
The study, required by the US Food and Drug Administration (FDA) for all new chemical entities,
was conducted to evaluate the cardiac safety of TZP-101, with a focus on cardiac repolarization as measured by the duration
of the QT interval in serial electrocardiograms (ECG). TZP-101 has a novel mechanism acting
as an agonist of the body’s ghrelin receptors, whereas other known gastrointestinal (GI) prokinetics act on serotonin
receptors and have been linked to life-threatening cardiac side effects related to QT interval prolongation resulting in their
restriction or removal from the market.
The trial was a double-blind, randomized, parallel study which compared
the ECG effects of TZP-101, given at a therapeutic (160μg/kg daily for 5 days) and a supratherapeutic dose (600μg/kg daily for 5 days), to placebo and moxifloxacin (a positive control
known to increase the QT interval) in 160 healthy men and women. The primary analysis was centered on a time-matched change
from baseline in corrected QT interval (QTc) based on an individual correction method.
“The extensive data, including a careful pharmacokinetic-pharmacodynamic analysis, from this
validated trial, clearly show that TZP-101 does not affect cardiac repolarization,” stated Gordana Kosutic, MD, Tranzyme’s
VP, Clinical and Regulatory Affairs. “The results further demonstrate that TZP-101 has no effect on heart rate, PR and
QRS interval duration or cardiac morphology, and thus continues to substantiate the compound’s pronounced cardiovascular
safety profile,” she added.
About TZP-101
TZP-101 is an intravenous ghrelin agonist that Tranzyme is evaluating in two concurrent Phase IIb
trials for the treatment of postoperative ileus (POI) and severe gastroparesis. The safety and pharmacokinetic profile of
TZP-101 has been extensively characterized in healthy subjects across multiple dose levels, and the prokinetic properties
of the compound have been well established in various animal models and a preliminary investigation in diabetic patients.
In addition to TZP-101, Tranzyme is developing an oral ghrelin agonist, TZP-102, currently in Phase I trials for the treatment
of mild-to-moderate gastroparesis and other chronic GI motility disorders.
About Postoperative Ileus
Postoperative ileus is a transient impairment of GI motility following abdominal or other surgery.
Common symptoms include abdominal distention or bloating, pain, nausea and vomiting, and inability to pass stools and tolerate
a solid diet. A delay in resuming a normal diet may lead to poor healing through a cascade of events. A greater risk for pulmonary
complications also exists, since POI may result in reduced patient mobility. POI is associated with an increased length of
hospital stay and is the most common cause of delayed hospital discharge after abdominal surgery. In the United States alone,
it is estimated that 22 million patients undergo surgical procedures requiring pain management and of these patients, 2.4
million undergo high risk open surgery each year (Source: Premier Database). No unrestricted treatments for POI have been
approved by the US Food and Drug Administration to date.
Tranzyme Pharma’s Ghrelin Agonist TZP-102 Demonstrates
Safety and High Oral Bioavailability in the Successful Completion of a Phase I Trial
RESEARCH TRIANGLE PARK, N.C.
and SHERBROOKE, Québec (June 17, 2008) - Tranzyme Pharma announced today the successful completion of a Phase I, placebo-controlled,
single ascending dose study of its orally administered ghrelin agonist, TZP-102. TZP-102 is the second drug candidate from
Tranzyme’s internal R&D efforts to reach clinical development. It is a potent prokinetic agent initially being developed
for the treatment of mild-to-moderate gastroparesis.
The Phase I study showed that TZP-102 has excellent oral bioavailability
in man and is safe and well-tolerated at all five doses (10-80 mg) tested. Most importantly, all doses achieved plasma concentrations
of TZP-102 above those associated with significantly increased rates of gastric emptying in a validated animal model. A multi-dose
Phase I study of TZP-102 in healthy volunteers has been initiated and the company expects to begin its first proof-of-concept
trial of TZP-102 in the fourth quarter of 2008.
TZP-102 is a product that complements Tranzyme’s pipeline of
first-in-class therapeutics for the treatment of both acute (hospital based) and chronic gastrointestinal and metabolic disorders
with significant unmet medical needs. Whereas TZP-102 is expected to be developed for the management of chronic gastrointestinal
disorders, Tranzyme’s lead drug candidate, TZP-101, is an injectable ghrelin agonist being evaluated in two concurrent
Phase IIb trials for the treatment of acute indications, severe gastroparesis and post-operative ileus (POI).
“Tranzyme’s
novel approach to drug discovery allows our compounds to retain the favorable characteristics of small molecules, such as
the high oral bioavailability demonstrated by TZP-102, while exhibiting the characteristics of large biomolecules, such as
tight receptor binding for high potency and exquisite target selectivity,” stated Helmut Thomas, Ph.D., DABT, Sr. Vice
President, Research and Preclinical Development of Tranzyme Pharma.
About TZP-102
TZP-102 is a first-in-class,
orally administered GI prokinetic agent that acts by a mechanism distinct from previously developed products for gastrointestinal
(GI) motility disorders. TZP-102 is an agonist of ghrelin receptors found in both the upper and lower GI tract. The drug is
expected to enter Phase II development in late 2008.
About Gastroparesis
Gastroparesis is an impairment or
paralysis of upper gastrointestinal tract function characterized by delayed gastric emptying in the absence of mechanical
obstruction. Symptoms of gastroparesis include post-prandial fullness, early satiety, abdominal pain, nausea, vomiting, and
weight loss. Disease severity ranges from mild to severe. Gastroparesis is a major complication of diabetes leading to metabolic
imbalance when liquid and food intake and absorption of oral medications is impaired. Gastroparesis may also result from abdominal
surgery or be idiopathic in nature. Current medications for the treatment of gastroparesis are only moderately effective and
many are associated with adverse neurological side effects. It is estimated that approximately 5 million patients suffer from
gastroparesis in the United States.
June 17, 2008-Tranzyme Pharma’s Ghrelin Agonist TZP-102 Demonstrates Safety
and High Oral Bioavailability in the Successful Completion of a Phase I Trial
RESEARCH TRIANGLE PARK, N.C. (June 17, 2008) - Tranzyme Pharma announced
today the successful completion of a Phase I, placebo-controlled, single ascending dose study of its orally-administered ghrelin
agonist, TZP-102. TZP-102 is the second drug candidate from Tranzyme’s internal R&D efforts to reach clinical development.
It is a potent prokinetic agent initially being developed for the treatment of mild-to-moderate gastroparesis.
The
Phase I study showed that TZP-102 has excellent oral bioavailability in man and is safe and well-tolerated at all five doses
(10-80 mg) tested. Most importantly, all doses achieved plasma concentrations of TZP-102 above those associated with
significantly increased rates of gastric emptying in a validated animal model. A multi-dose Phase I study of TZP-102 in healthy
volunteers has been initiated and the company expects to begin its first proof-of-concept trial of TZP-102 in the fourth quarter
of 2008.
TZP-102
is a product that complements Tranzyme’s pipeline of first-in-class therapeutics for the treatment of both acute (hospital
based) and chronic gastrointestinal and metabolic disorders with significant unmet medical needs. Whereas TZP-102 is expected
to be developed for the management of chronic gastrointestinal disorders, Tranzyme’s lead drug candidate, TZP-101, is
an injectable ghrelin agonist being evaluated in two concurrent Phase IIb trials for the treatment of acute indications, severe
gastroparesis and post-operative ileus (POI).
“Tranzyme’s
novel approach to drug discovery allows our compounds to retain the favorable characteristics of small molecules, such as
the high oral bioavailability demonstrated by TZP-102, while exhibiting the characteristics of large biomolecules, such as
tight receptor binding for high potency and exquisite target selectivity,” stated Helmut Thomas, Ph.D., DABT, Sr. Vice
President, Research and Preclinical Development of Tranzyme Pharma.
About TZP-102
TZP-102
is a first-in-class, orally administered GI prokinetic agent that acts by a mechanism distinct from previously developed products
for gastrointestinal (GI) motility disorders. TZP-102 is an agonist of ghrelin receptors found in both the upper and lower
GI tract. The drug is expected to enter Phase II development in late 2008.
June 5, 2008-Tranzyme Pharma to Present “Ghrelin
Agonist (TZP-101) Effects on Patients with Severe Symptomatic Diabetic Gastroparesis” at ADA 2008
RESEARCH TRIANGLE PARK, N.C. (June 5, 2008) - Tranzyme Pharma, a leading biopharmaceutical company that discovers and develops small molecule drugs
for the treatment of gastrointestinal and metabolic diseases, announced today that Dr. Niels Ejskjaer, MD, PhD of Aarhus University
Hospital, Denmark, will present Phase IIa trial results of Tranzyme’s first-in-class ghrelin agonist TZP-101 at the
American Diabetes Association, 68th Annual Meeting to be held in
San Francisco, CA, June 6-10, 2008.
Using scintigraphy and a standardized radiolabeled meal, this double blind, randomized, two-way
crossover study assessed the effects of TZP-101 on gastric emptying in 10 patients with long standing type 1 or type 2 diabetes
and severe symptomatic gastroparesis. Data show that TZP-101 induced a statistically significant reduction in half-emptying
time (p=0.043) and latency time (p=0.037) of the solid meal. It is of special significance that gastric emptying of the solid
meal was normalized in 30% of patients after a single TZP-101 infusion. Half-emptying and latency times for liquids were reduced
as well. Further, TZP-101 infusion decreased a cumulative meal-related symptom score in 5 of 8 patients with an overall improvement
of 24%. Postprandial fullness, the most frequent and severe symptom observed in the study, was reduced by 37%.
“No efficient pharmacotherapy exists for diabetic gastroparesis, thus threatening the health
of diabetic patients,” stated Dr. Ejskjaer, the study’s principal investigator. “This TZP-101 proof-of-concept
study data show a clinically relevant improvement of gastric emptying and suggest that TZP-101 is a promising agent for the
management of gastroparesis,” he added.
The abstract number 298-OR will be presented
in Room 130 of the Moscone Center on Monday, June 9, 2008 at 6:15pm.
About TZP-101
TZP-101 is an intravenous ghrelin agonist that Tranzyme is evaluating in two concurrent Phase IIb
trials for the treatment of severe gastroparesis and post-operative ileus (POI). The safety and pharmacokinetic profile of
TZP-101 has been extensively characterized in healthy subjects across multiple dose levels, and the prokinetic properties
of the compound have been well established in various animal models. In addition to TZP-101, Tranzyme is developing an oral
ghrelin agonist, TZP-102, for the treatment of mild-to-moderate gastroparesis and other chronic GI motility disorders.
About Gastroparesis
Gastroparesis is an impairment or paralysis of upper gastrointestinal
tract function characterized by delayed gastric emptying in the absence of mechanical obstruction. Symptoms of gastroparesis
include post-prandial fullness, early satiety, abdominal pain, nausea, vomiting, and weight loss. Disease severity ranges
from mild to severe. Gastroparesis is a major complication of diabetes leading to metabolic imbalance when liquid and food
intake and absorption of oral medications is impaired. Gastroparesis may also result from abdominal surgery or be idiopathic
in nature. Current medications for the treatment of gastroparesis
are only moderately effective and many are associated with adverse neurological side effects. It is estimated that approximately 5 million patients suffer from gastroparesis in the United
States.
RESEARCH TRIANGLE PARK, N.C. (March 3, 2008) - Tranzyme Pharma today announced that
it has commenced dosing in a Phase I study of TZP-102, the Company’s second generation, orally-administered ghrelin
agonist. TZP-102 is a potent prokinetic agent that Tranzyme is initially developing for the treatment of mild-to-moderate
gastroparesis, with other chronic gastrointestinal (GI) motility disorders to follow.
Tranzyme
develops small molecule drugs from its proprietary macrocyclic chemistry platform, MATCHTM, for the treatment of
GI and metabolic diseases. TZP-102 operates through the same mechanism of action as the lead drug, TZP-101, an intravenous
ghrelin agonist currently undergoing Phase IIb trials for the treatment of post-operative ileus (POI) and severe gastroparesis.
“We
are very excited to begin characterizing the safety and tolerability of TZP-102,” said Gordana Kosutic, M.D., Tranzyme’s
Vice President, Regulatory and Clinical Affairs. “We anticipate progressing TZP-102 into Phase II investigation by the
end of this year.”
“Gastrointestinal
disorders are expected to affect over 250 million people worldwide by 2012,” stated Vipin K. Garg, Ph.D., President
& CEO of Tranzyme Pharma. “Having two GI promotility drug candidates in the clinic is a great milestone for Tranzyme,
and is extremely encouraging for patients and caregivers alike since many competing promotility agents have safety issues
that have resulted in their restriction or removal from the market.”
About Gastroparesis
About Tranzyme
Pharma
Tranzyme
Pharma is a clinical stage biopharmaceutical company focused on developing and commercializing breakthrough small molecule
therapeutics for diseases where there is a significant unmet medical need. Tranzyme has developed a pipeline of novel drugs
for the treatment of gastrointestinal and metabolic diseases. For more information, please visit: www.tranzyme.com.
Tranzyme Pharma Receives IND Clearance for Its Oral Ghrelin Agonist,
TZP-102,
for the Treatment of Gastroparesis
Phase I Safety and Tolerability Trial to Begin
RESEARCH TRIANGLE
PARK, N.C. (January 29, 2008) - Tranzyme Pharma
announced today that the US Food and Drug Administration (FDA)
completed
its review of the Company's Investigational New Drug (IND)
application for TZP-102, Tranzyme's second drug candidate to
reach
clinical development.
Tranzyme is a clinical stage company developing small molecule drugs
for
the treatment of gastrointestinal (GI) and metabolic diseases.
TZP-102 operates on the same mechanism of action as the
Company's
lead product TZP-101, an intravenous ghrelin agonist currently
undergoing Phase IIb trials for the treatment
of two distinct acute
GI motility disorders: post-operative ileus (POI) and severe
gastroparesis. TZP-102 is a second
generation prokinetic drug that
Tranzyme intends to develop for the treatment of mild-to-moderate
gastroparesis and
other chronic GI motility disorders. A Phase I
safety and tolerability trial of TZP-102 will begin immediately.
"Advancing
TZP-102 into clinical development further strengthens our
product pipeline," commented Vipin K. Garg, Ph.D., President
& CEO of
Tranzyme Pharma. "Acceptance of this IND by the FDA represents a
significant milestone for Tranzyme as
well as for the technology
underlying the discovery and development of this product. TZP-102 is
the second clinical
candidate to originate from our proprietary
macrocyclic chemistry platform, MATCHTM," Dr. Garg added.
"We are genuinely
excited by the progression of TZP-102 to the clinic
as preclinical evidence suggests this oral prokinetic agent has
therapeutic
potential for symptomatic relief and management of
chronic gastroparesis," stated Gordana Kosutic, M.D., Tranzyme's Vice
President,
Regulatory and Clinical Affairs.
About Gastroparesis
Gastroparesis is a paralysis of upper gastrointestinal
tract function
characterized by delayed gastric emptying in the absence of
mechanical obstruction. Symptoms of gastroparesis
include post-
prandial fullness, early satiety, nausea, vomiting, and upper
abdominal pain. Disease severity ranges
from mild to moderate to
severe. Gastroparesis is a major complication of diabetes; it may
also result from abdominal
surgery and can be idiopathic in nature.
*NO EFFICACIOUS THERAPY IS AVAILABLE
FOR GASTROPARESIS. CURRENT
TREATMENTS ARE ONLY MODERATELY EFFECTIVE AND MANY ARE ASSOCIATED
WITH ADVERSE NEUROLOGICAL
SIDE EFFECTS.
It is estimated that approximately 5 million patients suffer from
Gastroparesis in the United
States.
MOVETIS NV -Belgian Biopharmaceutical Company
Two Movetis Compounds Successfully Progressing Through Phase II Clinical Trials In Gastrointestinal (GI) Disorders-Gastroparesis-Results
from clinical trial in 2009
Turnhout, 08 January 2008, Movetis NV, a European-based specialist pharmaceutical company, announced
today that M0002, an orally-active selective V2 vasopressin antagonist for the treatment of ascites has successfully completed
enrollment in a Phase IIa clinical trial, and that M0003, an innovative gastrokinetic compound for the treatment of paediatric
reflux and gastroparesis has now begun a Phase IIa clinical trial in patients with gastroparesis.
M0003 is a powerful, and specific, high affinity 5-HT4 agonist that stimulates upper GI motility and accelerates
gastric emptying at low dose. It is currently being studied for the treatment of gastroparesis, a disorder in which the stomach
takes too long to empty its contents, as well as paediatric reflux, or involuntary regurgitation of gastric contents into
the oesophagus. Results from the Phase IIa clinical trial of M0003 in gastroparesis are expected in 2009.
'We are encouraged
to see that our compounds are successfully progressing through research on time and within budgets. Obviously we are honoured
that the IWT institute feels our programme merits such a grant and we are committed to work with them to progress innovation
and create jobs in our region." commented Dirk Reyn, CEO of Movetis "Through these grants and the support of our distinguished
investors, we can pursue our path to discover, develop and ultimately commercialise innovative treatments targeting selected
GI conditions where patients do not get adequate relief from older drugs with less favourable benefit/risk profiles" .
*MOVETIS NV - founded 2007 - is an independent Belgian biopharmaceutical company which specializes
in developing compounds for gastrointestinal (GI) disorders. The current portfolio has been licensed from Janssen Pharmaceutica
NV, Belgium and Ortho-McNeil Pharmaceutical Inc., US, two Johnson & Johnson (JNJ) companies.
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