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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.
and SHERBROOKE, Québec
(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.
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