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news.Pain Therapeutics has discontinued its development of PTI-901, its late stage drug candidate for the treatment of irritable bowel syndrome, after a pivotal phase III trial failed to achieve its primary efficacy endpoint.
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Although PTI-901 demonstrated meaningful relief of symptoms in the second month of treatment, the drug did not demonstrate a meaningful benefit in the third month of treatment, which was defined as the primary endpoint for the trial. According to current regulatory standards, an experimental drug for chronic IBS needs to show efficacy at the end of a three-month treatment period.
The study compared a daily dose of PTI-901 against placebo in 600 women with documented IBS over a three-month treatment period.
In response to the discontinuation of development for the drug, Remi Barbier, president and CEO of Pain Therapeutics accentuated the positive. “This is an opportunity to sharpen our focus on our late-stage pipeline,” he said. “We’re ready to start 2006 with a strong balance sheet, a modest cash burn rate and two lead drug candidates in phase III clinical development.”