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Tranzyme
Pharma Presents Initial Phase IIa Data for its Novel Ghrelin
Agonist, TZP-101, in Patients with Diabetic Gastroparesis
Data Presented at American Diabetes Association’s 67th
Scientific Sessions in Chicago
RESEARCH TRIANGLE PARK, N.C. and
SHERBROOKE, Québec (June 26, 2007) - Tranzyme Pharma, a leading
biopharmaceutical company developing small molecule drugs for
the treatment of gastrointestinal and metabolic diseases, today
announced positive results for its novel ghrelin agonist,
TZP-101, in accelerating gastric emptying in diabetic patients
with gastroparesis. The data from a pilot Phase IIa study were
presented at the American Diabetes Association’s 67th Scientific
Sessions in Chicago, IL by Dr. Gordana Kosutic, Tranzyme’s VP of
Clinical and Regulatory Affairs. Tranzyme is developing TZP-101
as a first-in-class gastroprokinetic agent for the treatment of
severe gastroparesis and post-operative ileus (POI).
Using scintigraphy and a standardized meal, this double blind,
randomized, four-way crossover study assessed the efficacy of
three different dose levels of TZP-101 on gastric emptying in
patients with long standing Type 1 diabetes and severe
gastroparesis. The data showed that TZP-101 significantly
accelerated gastric emptying at all doses tested, whereas
placebo had no effect. These results suggest that TZP-101 is a
promising agent for the management of gastroparesis and that
further investigation is warranted.
“These data are very encouraging and I am looking forward to
continuing with the clinical investigation of TZP-101 in
patients with severe diabetic gastroparesis, as ghrelin is one
of the most attractive targets for the therapeutic management of
this serious medical condition,” said Dr. Niels Ejskjaer,
principal investigator from the Aarhus University Hospital,
Denmark.
Gastroparesis is a disorder characterized by delayed emptying of
food from the stomach. It exists in mild to moderate (chronic)
and severe (acute) forms and is a common disorder among
diabetics, and others with impaired gastric autonomic nerve
function. In severe cases, patients may require hospitalization
to treat pain, nausea, vomiting, and even malnutrition.
Gastroparesis represents a significant unmet medical need as
Propulsid™ (cisapride), the most widely used product for
treating this disorder was removed from the U.S. market in 2000
due to significant cardiovascular adverse effects.
Tranzyme earlier reported that TZP-101 demonstrated excellent
tolerability and safety, as well as a desirable pharmacokinetic
profile in healthy subjects in two Phase I clinical studies. The
Company plans to initiate full Phase II development of TZP-101
for both POI and severe gastroparesis in 3Q 2007. In addition to
the ongoing clinical testing of TZP-101 (an intravenous drug),
Tranzyme is developing a new oral ghrelin agonist, TZP-102.
Tranzyme expects to initiate Phase I clinical testing of TZP-102
in the first quarter of 2008 for the treatment of mild to
moderate chronic gastroparesis.
“The Company is making great progress in the development of
TZP-101,” said Dr. Vipin Garg, President & CEO of Tranzyme
Pharma. “Tranzyme’s novel ghrelin agonists (TZP-101 and TZP-102)
are promising breakthrough drugs with huge commercial potential.
Most prokinetic agents under development and on the market act
on predominantly central nervous system receptor targets that
are also found in the GI tract. Many show potentially serious
CNS side effects. Our small molecule ghrelin agonists target a
receptor that is more directly involved with regulating
gastrointestinal motility.”
About Gastroparesis
Gastroparesis results from dysfunction of the nerves of the
stomach, leading to postprandial fullness, bloating, early
satiety, nausea and vomiting. The three most common etiologies
of gastroparesis are diabetes (an estimated 30% of gastroparesis
patients), unknown etiology (36%), and post-surgical causes
(13%). The prevalence rate of gastroparesis is especially high
among diabetic patients, as up to 50% of diabetics worldwide are
reported to suffer from gastroparesis. Gastroparesis has serious
implications in diabetic patients, where failure to tolerate
food and oral medications may lead rapidly to metabolic
instability and the need for immediate treatment or
hospitalization. Alternative therapeutic approaches, applicable
in limited cases, include surgery, botulinum toxin injections
(to reduce pyloric tone) and electrical stimulation of the gut.
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