A second Phase III miss with its functional dyspepsia drug, ITAX (itopride), prompted Axcan Pharma Inc. to discontinue further work in that indication.
The company did not release detailed results from the North American Phase III trial, but reported that ITAX failed to demonstrate a statistically significant effect in improving the symptoms of upper abdominal pain and fullness, as assessed by the Leeds Dyspepsia Questionnaire. Data also lacked statistical significance based on efficacy measured by the Patient Global Assessment questionnaire.
Axcan said it would continue analyzing data, but it believes it's unlikely that there is enough evidence of efficacy to warrant further clinical development in functional dyspepsia, a condition characterized by upper abdominal pain that has no apparent organic cause.
The latest clinical news came seven months after Mont St.-Hilaire, Quebec-based Axcan reported a miss in its first Phase III study of ITAX, causing the company's stock to fall 28 percent, closing at $11.76. (See BioWorld Today, Feb. 23, 2006.)
Shares of Axcan (NASDAQ:AXCA) slipped 55 cents on Thursday's news to close at $12.65.
The company previously had hoped to pursue ITAX against diabetic gastropathy; however, despite showing positive trends in two mechanistic studies, the drug's effects again were not strong enough for Axcan to move forward. Results of those studies are expected to be presented next month at the American College of Gastroenterology's scientific meeting in Las Vegas.
Elsewhere in its pipeline, Axcan has NCX-1000, a nitric oxide-donating derivative of ursodiol, in development with Sophia Antipolis, France-based NicOx SA for portal hypertension. That program is in a Phase IIa study.
Axcan completed a Phase I study to evaluate the safety and tolerability of ursodiol disulfate, and is in Phase I with NMK 150, a protease pancrelipase preparation for relief of pain in small duct chronic pancreatitis. NMK 150 is partnered with Uetersen, German-based Nordmark GmbH.
The company is awaiting FDA review of Holytide, a capsule therapy aimed at eradicating Helicobacter pylori, and hopes to launch the product as early as the first half of 2007.