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European phase 2 trial to test IBD drug candidate

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Abivax announced that it has completed enrollment for a trial that will test the safety and efficacy of ABX464, an inflammatory bowel disease drug candidate, in patients with moderate-to-severe ulcerative colitis.

The trial will focus on patients who have failed or are intolerant to immunomodulators, anti-TNF alpha, Entyvio (vedolizumab, Takeda) or corticosteroids, according to press release.

“Too many patients still do not respond or stop responding to current treatments,” Severine Vermeire, MD, head of the IBD center at the University Hospitals in Leuven, Belgium, and principal investigator of the trial, said in the press release. “We are looking forward to the top-line data from this study and also to transferring as many patients as possible onto the one-year, open-label extension study with ABX464, which will provide us with very important long-term safety and efficacy data.”

The phase 2A clinical trial includes 30 patients from 17 centers across Belgium, France, Germany, Austria, Hungary, Poland and Czech Republic. Investigators randomly assigned patients 2:1 to receive either 50 mg of ABX464 or a placebo. The study will use monitoring technology, like numerical recording of colonoscopies with centralized reading, to track potential treatment effects, according to the press release.

Patients who complete the two-month trial can join a 12-month, open label follow-up study. The researchers have already recruited 10 patients for the extension study.

"Abivax is very pleased to announce the completion of enrollment in this first clinical trial exploring ABX464 for treatment of inflammatory indications," Hartmut Ehrlich, MD, CEO of Abivax, said in the press release. “I would like to highlight the outstanding enthusiasm and dedication of [Dr. Vermeire] and thank the clinical trial sites, which kept recruitment on target, allowing us to report the top-line results from this important clinical trial in the autumn of this year.”

Disclosures: Ehrlich is employed by Abivax. Healio Gastroenterology and Liver Disease could not confirm Vermeire’s relevant financial disclosures at the time of publication.