Tranzyme Inc. (TZYM) Monday said it is discontinuing the second mid-stage trial of its lead drug TZP-102 for treatment of diabetic gastroparesis, due to insufficient efficacy.
Investors were disappointed by the news, as this is the second lead drug that the company has given up this year. Tranzyme shares are currently trading down 22 percent on the Nasdaq.
Gastroparesis, which literally means paralyzed stomach, is a disorder in which the stomach takes too long to empty food into the small intestine. Diabetes is the most common cause of gastroparesis, and it is estimated that about 12 percent of patients with diabetes suffer from gastroparesis worldwide.
The only medication approved by the FDA for treating gastroparesis - Reglan (metoclopramide), carries a black box warning because of the danger of serious side effects like tardive dyskinesia. There is currently a large unmet medical need for the treatment of gastroparesis due to the lack of safe and effective therapies.
Tranzyme, a clinical stage biotechnology company, said the decision was made after the analysis of patients' responsiveness to three daily oral doses of TZP-102 compared to placebo at the end of weeks 4 and 8 of the 12 week trial.
The results are consistent with the findings of a prior Phase 2b trial in that there was a very large placebo effect and no treatment effect, the company said.
In March, Tranzyme's bowel drug candidate - Ulimorelin also disappointed in a phase 3 trial. Ulimorelin was intended to accelerate gastrointestinal recovery in subjects who had undergone partial bowel resection. The company has stopped development and regulatory activities related to Ulimorelin.
Tranzyme currently also has two preclinical drug candidates - TZP-201 for the treatment of various forms of moderate-to-severe diarrhea and TZP-301 for the treatment of obesity and other metabolic diseases.
TZYM is currently trading at $0.60, down $0.14 or 18.92%, on a volume of 0.5 million shares.
by RTT Staff Writer
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