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Tranzyme
Pharma Expands Clinical Program of its Novel Ghrelin Agonist,
TZP-101, to Include Patients with Gastroparesis
RESEARCH TRIANGLE PARK, N.C. and
SHERBROOKE, Québec (September 21, 2006) - Tranzyme Pharma
announced today that the Company has amended the IND for its
novel small molecule ghrelin agonist, TZP-101, to include
patients with gastroparesis. Tranzyme has been developing
TZP-101 as a potent prokinetic agent for the treatment of
post-operative ileus (POI). Under the amended IND, Tranzyme has
initiated a single-dose study in diabetic patients suffering
from gastroparesis. This new study will provide a lead-in to
more detailed Phase II evaluation of TZP-101 in both POI and
gastroparesis.
Gastroparesis is a gastrointestinal disorder characterized by
delayed emptying of the stomach. It exists in acute and chronic
forms and is a common disorder among patients with diabetes.
Patients presenting with acute episodes of gastroparesis require
immediate hospitalization to manage pain, nausea, vomiting,
glucose dysregulation, fluid and electrolyte imbalance, and
potential malnutrition. The most potent product for treating
gastroparesis, Propulsid® (cisapride), achieved $1 billion in
global sales, but was withdrawn from the market in 2000 due to
adverse side effects.
“The Company is making significant progress in the development
of TZP-101,” said Gordana Kosutic, M.D., VP, Clinical &
Regulatory Affairs for Tranzyme Pharma. “Recent investigator
initiated clinical studies of the native ghrelin peptide have
shown that ghrelin accelerates gastric emptying in patients with
gastroparesis. Since gastroparesis is highly prevalent among
diabetics, we chose to target this patient population in this
proof of principal study. The results from this study will give
us preliminary data on the efficacy of TZP-101 in reversing
delayed gastric emptying.”
In a previous Phase I single-dose study, Tranzyme reported that
TZP-101 demonstrated excellent tolerability and safety, and a
desirable pharmacokinetic profile in healthy subjects. The
Company plans to initiate full Phase II development of TZP-101
in early 2007. In addition to the ongoing clinical testing of
TZP-101, Tranzyme is developing a second generation ghrelin
agonist, TZP-102, as an oral product. Tranzyme expects to
initiate Phase I clinical testing of TZP-102 in the second half
of 2007 for the treatment of mild to moderately severe
gastroparesis.
“TZP-101 and TZP-102 are promising first-in-class drugs with
tremendous commercial potential”, said Vipin K. Garg, Ph.D.,
President & CEO of Tranzyme Pharma. “Unlike TZP-101, most
prokinetic agents under development and on the market target the
central nervous system with potentially serious side effects.
The amended IND represents a significant milestone for Tranzyme
Pharma as TZP-101 is the Company’s first product to be dosed in
patients.”
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