Abivax has enrolled the first subject in the Phase IIb ENHANCE-CD clinical trial of its lead investigational drug candidate obefazimod as a potential treatment for Crohn’s disease.
The double-blind, multi-centre, randomised, placebo-controlled trial is structured into three treatment portions: a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase.
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It is designed to assess the efficacy and safety of the once-daily dose of the drug as both an induction and maintenance therapy when compared to a placebo.
The trial will enrol adult patients with moderately to severely active Crohn’s, who have had an inadequate response to conventional or advanced therapies.
During the 48-week extension phase, the primary objective will shift to evaluating the long-term safety and tolerability of obefazimod versus placebo.
A small molecule drug, obefazimod is said to have shown promise in enhancing the expression of microRNA miR-124.
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By GlobalDataAbivax chief medical officer Fabio Cataldi said: “The enrolment of the first patient in our Phase IIb trial marks a significant step forward in meeting the need for a convenient, oral, once-daily treatment option for people with moderately to severely active Crohn’s disease.
“This milestone brings us closer to addressing the unmet needs of patients seeking effective therapies with fewer burdens on their daily lives.”
Previous Phase II trials in ulcerative colitis (UC) patients have yielded positive data, leading to the launch of a global Phase III clinical trial programme, the ABTECT Program, which began enrolling patients in the US in October 2022.
The company also reported interim efficacy and safety analysis data from an open-label maintenance (OLM) study enrolling UC patients after the Phase IIa and Phase IIb OLM studies assessing once-daily doses of 50mg obefazimod.
In the study, obefazimod treatment led to the maintenance of clinical remission and a safety profile in line with prior studies of the 25mg dose of the drug for up to an additional two years.
