Investigational ABX464 Enhances Remission Rates, Mucosal Healing in Ulcerative Colitis Patients in Phase 2a Trial

Investigational ABX464 Enhances Remission Rates, Mucosal Healing in Ulcerative Colitis Patients in Phase 2a Trial
Abivax's small, anti-inflammatory molecule ABX464 significantly increased clinical remission and mucosal healing over placebo in patients with moderate to severe active ulcerative colitis resistant to other therapies, top-line results from a Phase 2a clinical trial show. “These impressive clinical trial data are indicative of the potential for ABX464’s unique mechanism of action to safely and effectively bring substantial clinical benefit to patients who are not adequately helped by currently available therapeutics and are struggling from the devastating consequences of this inflammatory disease,” Hartmut Ehrlich, MD, CEO of Abivax, said in a press release. “Based on these exciting results, Abivax will initiate, without delay, a phase 2b dose-ranging study in Europe, with potential input from US KOLs [key opinion leaders] and FDA on study design. Furthermore, these data strongly encourage us to pursue phase 2 clinical trials in other inflammatory indications including Crohn’s disease,” he said. The ABX464-101 trial (NCT03093259), which began enrolling participants in November 2017, investigated the safety and effectiveness of ABX464 in 32 people with moderate to severe active ulcerative colitis who had failed or were intolerant to immunomodulators, such as anti-tumor necrosis alpha,
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