Pain Therapeutics stops work on PTI-901 for irritable bowel syndrome after it fails trial

New York, Dec. 9 - Pain Therapeutics, Inc. said it has stopped work on its PTI-901 drug for irritable bowel syndrome after the chemical failed to achieve the required performance in a phase 3 clinical trial.

The drug did not demonstrate a meaningful benefit in the third month of treatment, which was defined as the primary endpoint, the South San Francisco, Calif., biopharmaceutical company.

Pain Therapeutics noted that PTI-902 showed a favorable safety profile and patients reported statistically meaningful relief of symptoms in the second month of treatment.

However, the company said, "according to current regulatory standards, an experimental drug for chronic IBS [irritable bowel syndrome] needs to show efficacy at the end of a three-month treatment period.

"The company believes this study was well designed to detect any durable benefits of PTI-901 versus placebo in a large patient population with IBS."

"This is an opportunity to sharpen our focus on our late-stage pipeline," said Remi Barbier, president and chief executive officer of Pain Therapeutics, in a news release.

"We're ready to start 2006 with a strong balance sheet, a modest cash burn rate and two lead drug candidates in phase 3 clinical development. In addition, in 2006 we plan to add depth to the pipeline by announcing, with our commercial partner, Investigational New Drug applications for one or more new abuse-resistant opioid painkillers."

Pain Therapeutics expects to have over $200 million of cash at the end of 2005 and a net cash burn rate of under $15 million in 2006.

The randomized, double-blinded, multi-center U.S. trial for PTI-901 involved 600 women.

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