Axcan releases disappointing results for ITAX phase 3 clinical study

By Elaine Rigoli

Tampa, Fla., Feb. 22 - Axcan Pharma, Inc. announced that results of the ITAX (Itopride) international phase 3 clinical trial showed that Itopride, a drug developed for the treatment of functional dyspepsia, did not meet its primary endpoint.

The results did not confirm the efficacy observed in other studies, including the phase 2 clinical trial, according to a company news release.

The company said it will continue to analyze the efficacy data from this phase 3 trial; the analysis, together with the results of the North American phase 3 study, should provide a better understanding of the outcome.

These findings will enable the company to decide on the continuation of the ITAX functional dyspepsia program. Axcan will continue the development of this compound in other areas such as diabetic gastropathy, the release said.

"We are obviously surprised with the results of the Itopride international phase 3 trial, particularly in view of the positive results seen in the soon-to-be published phase 2 trial and in the preclinical data that provided strong mechanistic support for Itopride," said Frank A.G.M. Verwiel, MD, Axcan president and chief executive officer, in a company statement.

"The results of the study did, however, confirm the safety profile of the product candidate.

"While efficacy results are disappointing for all stakeholders, we intend to examine all potential factors relating to this outcome and are therefore conducting additional analyses including by subgroup populations, with a view to understanding the discrepancy between the results of the phase 2 trial and the international phase 3 trial. Another important element of information will be the results of the North American phase 3 trial expected to be announced by the end of the first half of calendar 2006."

Axcan is a specialty pharmaceutical company specialized in the field of gastroenterology. The company is based in Mont-Saint-Hilaire, Quebec.

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