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FDA accepts investigational NDA for ulcerative colitis therapy

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William J. Sandborn

The FDA accepted the investigational new drug application for ABX464 for the treatment of patients with moderate to severe ulcerative colitis, according to the drug’s manufacturer.

Currently, researchers are assessing ABX464 (Abivax) across 15 European countries and in Canada in 232 patients with moderate to severe UC. This FDA clearance allows the phase 2b trial to extend into the United States.

Recent phase 2a data demonstrated that 75% of patients who had previously failed other therapies were in clinical remission after receiving study drug.

“I am pleased that this promising drug candidate can now move forward with phase 2b testing in the U.S.,” William J. Sandborn, MD, director of the Inflammatory Bowel Disease Center at UC San Diego Health and the study’s principal investigator, said in a company-issued release. “Based on the data from previous trials, ABX464 has the potential to address the high unmet medical need of UC patients in the U.S. and worldwide, with many of them not responding or losing responsiveness to currently available treatments.”