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Tranzyme
Pharma Receives FDA Fast Track Designation for its Novel Ghrelin
Agonist, TZP-101, for the Treatment of Severe Gastroparesis
RESEARCH TRIANGLE PARK, N.C.
and SHERBROOKE, Québec (July 12, 2007) - Tranzyme Pharma,
a leading biopharmaceutical company developing small molecule
drugs for the treatment of gastrointestinal and metabolic
diseases, today announced that the company has received fast
track designation for its novel ghrelin agonist, TZP-101, for
the treatment of severe gastroparesis. Tranzyme is developing
TZP-101 as a first-in-class prokinetic agent for the treatment
of severe gastroparesis and post-operative ileus (POI).
Under the FDA Modernization Act of 1997, the Fast Track Program
mandates the FDA to facilitate development and expedite review
of a drug intended to treat a serious or life-threatening
condition that demonstrates the potential to address an unmet
medical need. Support of this fast track designation was based
on positive Phase IIa data from a clinical study of TZP-101 in
diabetic patients with severe gastroparesis, as well as from
pre-clinical studies demonstrating that TZP-101 has the
potential to address this unmet medical need.
“The Food and Drug Administration’s fast track designation for
TZP-101 highlights the large unmet medical need for a treatment
for severe gastroparesis,” said Gordana Kosutic, M.D., VP of
Clinical and Regulatory Affairs for Tranzyme Pharma. “In 2005,
an estimated 150,000 patients were hospitalized with a diagnosis
code of gastroparesis; these patients had gastroparesis listed
as either a primary or secondary diagnosis at the time of
discharge. Many of these patients are diabetics who have
inadequate blood glucose control. Currently, no satisfactory
treatment exists for this severe condition. Metoclopramide, the
only drug approved by the FDA for gastroparesis, is associated
with unwanted adverse events including extrapyramidal reactions
and tardive dyskinesia.”
About Gastroparesis
Gastroparesis is a disorder characterized by delayed emptying of
food from the stomach. Gastroparesis results from dysfunction of
the nerves of the stomach, leading to postprandial fullness,
bloating, early satiety, nausea and vomiting. Gastroparesis
exists in mild to moderate (chronic) and severe (acute) forms.
In severe cases, patients may require hospitalization to treat
pain, nausea, vomiting, and malnutrition. In particular,
gastroparesis has serious implications in diabetic patients,
where failure to tolerate food and oral medications may rapidly
lead to metabolic instability and the need for immediate
treatment or hospitalization. Gastroparesis affects an estimated
1.2 million diabetics in the US. In 2005 there were 150,000
hospitalizations in the United States where gastroparesis was
the primary or the secondary diagnosis. The incidence of
gastroparesis has increased dramatically as the incidence of
diabetes and obesity has increased.
About TZP-101
TZP-101 is a potent, small molecule ghrelin receptor agonist
that Tranzyme is developing as an intravenous drug for the
treatment of severe gastroparesis and post-operative ileus. The
safety and pharmacokinetic profile of TZP-101 has been
characterized in 50 healthy subjects across multiple dose
levels. A Phase IIa pilot clinical trial testing its efficacy in
diabetic patients with severe gastroparesis has been completed.
Tranzyme recently reported initial data showing that TZP-101
significantly accelerates gastric emptying and improves symptoms
characteristic of gastroparesis. Tranzyme plans to initiate full
Phase II development of TZP-101 for both severe gastroparesis
and POI in 3Q 2007.
TZP-101 is a new chemical entity originating from Tranzyme’s
internal chemistry-based drug discovery program.
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