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Tranzyme Pharma
Receives IND Clearance for its Novel Ghrelin Agonist, TZP-101
Company to Initiate Phase I
Trial for Post-Operative Ileus
RESEARCH TRIANGLE PARK, N.C.
and SHERBROOKE, Québec (January 10, 2006) -Tranzyme
Pharma, a leading biopharmaceutical company developing novel
mechanism-based therapeutics for the treatment of
gastrointestinal (GI) and metabolic disorders, today announced
that the U.S. Food and Drug Administration has cleared its
Investigational New Drug (IND) application for TZP-101, a new
chemical entity originating from Tranzyme Pharma's proprietary
small molecule macrocyclic chemistry. 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
GI motility disorders.
Ghrelin is a peptide hormone secreted by the stomach and small
intestine and plays a physiological role in the stimulation of
GI motility. Animal data suggest that ghrelin accelerates
gastric emptying, enhances small bowel transit, and reverses
delayed GI transit stemming from surgery or opioid therapy.
Clinical studies have shown that exogenous administration of
ghrelin peptide accelerates gastric emptying and stimulates
interdigestive motility in healthy volunteers and gastroparesis
patients.
In preclinical studies, TZP-101 has shown exceptional in vivo
efficacy. The gastroprokinetic activity of TZP-101 has been
demonstrated in animal models measuring gastric emptying in
naïve rats, and in the treatment of rats with delayed GI transit
caused by high caloric intake (i.e. a model of gastroparesis),
abdominal surgery (i.e. a model of POI), and pharmacological
means (i.e. morphine). Importantly, concurrent studies in rats
have demonstrated that TZP-101 does not elicit growth hormone
release at gastroprokinetic doses, in contrast to other ghrelin
agonists.
The Phase I trial will be a single-center, randomized,
double-blind, placebo-controlled, dose-escalation study
designed to evaluate safety, tolerability, pharmacokinetic, and
pharmacodynamic parameters of TZP-101.
"The initiation of Phase I studies is a significant step in the
development of a mechanism-based therapeutic for the management
of delayed gastric emptying," said Gordana Kosutic, M.D., Vice
President of Clinical and Regulatory Affairs for Tranzyme
Pharma. "Disorders of delayed gastric emptying, such as POI and
gastroparesis, currently have limited therapeutic options. We
anticipate having data available from first-in-man study by
3Q2006."
"This announcement marks Tranzyme's transition to a
clinical-stage company and is a major milestone in our continued
growth," said Vipin K. Garg, Ph.D., President and Chief
Executive Officer. "It also validates our chemistry technology
in the successful development of a small molecule macrocyclic
compound as a clinical candidate. Tranzyme's ghrelin agonist
represents a considerable therapeutic and commercial opportunity
as we continue to develop it for other unmet GI indications such
as diabetic gastroparesis."
About post-operative ileus (POI)
POI is the impairment of GI motility that routinely occurs after
major surgeries and contributes significantly to post-operative
morbidity, prolonged hospitalization and increased health care
costs. The pathophysiology of POI is multifactorial and its
duration correlates with the degree of surgical trauma. The
morbidity related to POI includes increased post-operative pain,
increased nausea and vomiting, delayed resumption of food
intake, poor wound healing, delayed post-operative mobilization,
and increased risk of other post-operative complications (e.g.,
pneumonia and pulmonary embolism). Annually, over 2 million
surgeries in the U.S., in particular colonic surgeries, are at
high risk for the development of POI.
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