Phase 2 Trial of Oral Treatment for Ulcerative Colitis Expanding to US, Abivax Says

Phase 2 Trial of Oral Treatment for Ulcerative Colitis Expanding to US, Abivax Says
The U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for ABX464, Abivax’s treatment candidate for ulcerative colitis (UC), allowing the company to expand its Phase 2b trial assessing the medicine's safety and efficacy to the U.S. The trial, called ABX464-103 (NCT03760003), is ongoing in 15 European countries and in Canada. It's expected to enroll up to 232 adults with moderate-to-severe UC, testing various daily doses (25 mg, 50 mg, and 100 mg capsules) against a placebo for 16 weeks. Patient enrollment is still underway at several existing sites, and expected to open at U.S. sites in the coming months. More information is available here. "We are very excited about the green light from the FDA, which is a very important milestone in Abivax's global development strategy for our lead compound, ABX464," Hartmut J. Ehrlich, MD, chief executive officer of Abivax, said in a press release. "By expanding the ongoing … study of ABX464 to the U.S., Abivax is aiming to make this new potential treatment option available to a substantial number of UC patients in need of new therapeutic solutions," Ehrlich said. ABX464 is an oral small molecule with a new mechanism of action. It is designed to promote the production of a microRNA molecule (miRNA-124) that has strong anti-inflammatory properties. MicroRNAs are tiny RNA molecules that control the expression of several genes; RNA molecules can serve as a template for proteins produced in gene expression. Abivax recently presented data from an open-label extension study (NCT03368118), called ABX464-102, showing that 75% of patients with moderate-to-severe UC who failed to respond to other treatments attained clinical remission — became symptom-free — after  o
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