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Tranzyme Pharma
Announces Successful Completion of Phase I Clinical Trial of its
Novel Ghrelin Agonist, TZP-101
RESEARCH TRIANGLE PARK, N.C. and
SHERBROOKE, Québec (May 10, 2006) -Tranzyme Pharma announced
today that it has successfully completed a Phase I clinical
trial of its first drug candidate, TZP-101, a new chemical
entity originating from the Company’s proprietary small molecule macrocyclic chemistry technology. TZP-101 is a selective ghrelin
receptor agonist with potent gastroprokinetic properties that
represents the first in its class to enter into a clinical
trial. Tranzyme Pharma is developing TZP-101 as a
mechanism-based therapy for post-operative ileus (POI) and other
gastrointestinal (GI) motility disorders. The Phase I study
demonstrated that TZP-101 is safe and well tolerated in healthy
subjects and that the safety and pharmacokinetic profile of the
compound support further clinical development.
“We are extremely excited to reach this important milestone with
TZP-101, our first product to enter clinical development,” said
Vipin K. Garg, Ph.D., President & CEO of Tranzyme Pharma. “With
TZP-101 leading the way, Tranzyme is building a rich internal
pipeline of novel drug candidates to address important medical
needs including GI motility disorders, obesity and diabetes. Our
rapid progress in drug discovery and development is clear
testimony to the robustness of our proprietary chemistry
technology and our ability to design agonists and antagonists
with selective and potent activity on pharmaceutically relevant
targets.”
The first-in-man trial just completed was an ascending dose,
placebo-controlled study in which healthy volunteers (total 48
subjects) were randomly assigned to receive one of six TZP-101
dose levels or placebo as a 30-minute intravenous infusion.
“These data demonstrate that the tolerability, safety and a
highly attractive pharmacokinetic profile of TZP-101 support
continuing clinical development,” said Gordana Kosutic, M.D.,
Vice President of Clinical and Regulatory Affairs for Tranzyme
Pharma. “The Company will now proceed to evaluate the safety and
pharmacodynamic activity of the drug in a multiple-dose study in
healthy subjects and in a single-dose study in Type 1 diabetic
patients experiencing delayed gastric emptying.”
In extensive preclinical studies, Tranzyme’s ghrelin agonists
have been shown to stimulate gastric emptying in naïve rats, and
to reverse delayed GI transit in rats caused by abdominal
surgery (a model of POI), high caloric intake (a model of
gastroparesis), and treatment with morphine (a model of opioid-induced
GI dysfunction). Tranzyme is developing its ghrelin agonists
both as an intravenous therapy (TZP-101) for acute,
hospital-based applications and as an orally administered
product (TZP-102) for chronic GI disorders.
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