Abivax reports excellent efficacy and safety of ABX464 in phase 2b clinical trial in ulcerative colitis and plans to proceed to phase 3

  • PARIS, France, May 24, 2021 – 6:30 pm (CEST) – Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, announces positive phase 2b 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 8 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.

    The phase 3 clinical program with ABX464 in UC is expected to start by year end.[3]

    Abivax’s clinical trial steering committee (Prof. Séverine Vermeire, Prof. William Sandborn and Prof. Bruce Sands) was convened on May 22, 2021 and reviewed and endorsed the phase 2b induction and maintenance top-line results and the corresponding conclusions.

Read the full press release here.