ABIVAX: ABX464 shows excellent long-term efficacy data in Abivax's phase 2b maintenance Trial in ulcerative colitis - Seite 3

Importantly, 36/73 patients (49.3%) who were not in clinical remission at the end of induction achieved a de novo clinical remission during the first year of maintenance.

Remarkably, the clinical remission rate for patients who did not show at least a clinical response at the end of the induction phase was 55.9% (PP) and 50% (ITT) after 48 weeks of treatment, demonstrating that long-term administration of ABX464 provided substantial clinical benefits also for these patients.

During the induction and the maintenance phases of the phase 2b study, ABX464 continued to show a good safety and tolerability profile, confirming the data already generated in over 850 patients and volunteers treated with ABX464 so far.

In May and September 2021, Abivax already announced the top-line and full results , respectively, of this randomized, placebo-controlled phase 2b trial of ABX464 in moderate to severe ulcerative colitis patients following induction treatment.

254 patients with moderate to severe active ulcerative colitis were enrolled in this phase 2b trial and randomized to three once-daily oral ABX464 treatment groups (25mg, 50mg and 100mg) or placebo. 50% of these patients had inadequate response, loss of response, or intolerance to biologics and/or JAK inhibitors treatments while the other 50% were refractory to conventional treatments. Endoscopies were read centrally and in a blinded fashion by independent reviewers. The baseline disease characteristics were well balanced across all ABX464 dose groups and the placebo group. Enrolled patients suffered from longstanding UC (with a mean duration of 7.4 to 8.8 years by treatment group) and 71.4% of the patients showed a severe disease profile (modified Mayo Score of 7 to 9 at screening).

Phase 2a ABX464 maintenance study in ulcerative colitis - 15 patients completed 3 ^rd year of treatment
In addition to the phase 2b maintenance results, Abivax recently also reported efficacy data from its ongoing phase 2a maintenance study in UC.

15 out of the 22 patients who were initially enrolled into the phase 2a maintenance study completed the third year of treatment with 50mg once daily oral ABX464 as of June 29, 2021.

Among the 13 patients who had centrally read endoscopies at the completion of year 3, 11 patients (85%) were still in clinical remission, of which 7 patients (54%) had an endoscopic remission (endoscopic subscore=0) and 11 patients had an endoscopic remission or improvement (endoscopic subscore=0 or 1).