French clinical-stage biotech Abivax (Euronext Paris: ABVX) has released positive Phase IIb clinical induction and preliminary maintenance study results. 254 patients with moderate to severe ulcerative colitis (UC) were treated with ABX464, a small molecule for once-daily administration with a first-in-class mechanism of action.
The top-line data showed significant clinical efficacy in the overall patient population on primary and key secondary endpoints and a good safety profile of ABX464 during eight weeks of induction treatment. Importantly, the overall drop-out rate of patients in the study was only 9%, which is remarkable in view of the Covid-19 situation.
Furthermore, after 48 weeks of open-label maintenance treatment with ABX464, preliminary data from the first 51 patients showed further increased and durable clinical and endoscopic efficacy.
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