Belgium Approves Extension Trial of Abivax’s Ulcerative Colitis Therapy

Belgium Approves Extension Trial of Abivax’s Ulcerative Colitis Therapy
Regulators in Belgium have approved Abivax's request for a long-term extension of the company's ongoing Phase 2a trial of ABX464 as a treatment for ulcerative colitis. It said it expects approvals from regulators in a number of other European countries as well. Abiva originally developed ABX464 to treat HIV/AIDS. But it discovered that the compound had anti-inflammatory properties that could make it useful for treating inflammatory bowel diseases such as ulcerative colitis. Preclinical-trial studies showed that ABX464 reduced inflammation and promoted gut tissue repair in mice with bowel diseaes. The protective effect on the gut continued after treatment, the studies demonstrated. The results led to the Phase 2a proof-of-concept trial named ABX464-101 (NCT03093259) that is assessing the treatment’s safety and ability to help patients with moderate-to-severe colitis. Researchers are continuing to enroll patients who have failed to respond to, or are unable to tolerate, other treatments, including immunomodulators, anti-tumor necrosis factor alpha (TNFa), vedolizumab and corticosteroids. Abivax is conducting the trial at 18 centers in France, Belgium, Germany, Hungary, Poland, the Czech Republic, Spain and Austria. Participants are being randomized to receive either 50 mg of oral ABX464 or a placebo once a day for eight weeks. Preclinical-trial studies showing that ABX464 is safe prompted regulators in Belgium to approve the idea of a long-te
Subscribe or to access all post and page content.

Leave a Comment

Your email address will not be published. Required fields are marked *