Abivax SA announced that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, announced that a scientific article has been published in the peer-reviewed journal "The Lancet Gastroenterology & Hepatology", the gastroenterology and hepatology research journal. The publication highlights that all doses of obefazimod tested during the induction study (25mg, 50mg and 100mg) significantly improved the condition of patients suffering from moderate to severe, active ulcerative colitis compared to placebo, as measured by changes in Modified Mayo Score from baseline at week 8. Further, the data show that patients on continuous daily treatment with 50mg obefazimod during the 48 weeks maintenance trial experienced new or maintained clinical response, clinical remission, endoscopic improvement and endoscopic remission. 254 patients with moderate to severe active ulcerative colitis were enrolled into the phase 2b clinical study and dosed with obefazimod within three once-daily oral 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 inhibitor treatments while the other 50% were refractory to conventional treatments. Endoscopies were read centrally and blinded by independent reviewers. The baseline disease characteristics were well balanced across all dose groups of obefazimod and the placebo group.

Enrolled patients suffered from longstanding UC with an overall mean disease duration of 8.05 years and 71.4% of the patients showed a severe disease profile (baseline modified Mayo Score of 7 to 9 points). At week 8 of the induction study, the primary endpoint (statistically significant reduction of Modified Mayo Score) was met with once-daily administration of obefazimod (25mg, 50mg, 100mg). Further, all key secondary endpoints, including endoscopic improvement, clinical remission, clinical response and the reduction of fecal calprotectin showed significant difference in patients dosed with obefazimod compared to placebo.

Importantly, obefazimod also showed rapid efficacy in patients who were previously exposed to biologics and/or JAK inhibitors treatment. 97.7% (217/222) of all patients who completed the phase 2b induction study, irrespective of treatments or treatment outcome during the induction phase, enrolled in the open-label maintenance study to evaluate the long-term safety and efficacy profile of obefazimod for up to two years. Out of these 217 patients, the 48-week data of the first 78 patients were available at the time of manuscript preparation.

Meanwhile, Abivax confirmed the data of these first 78 maintenance patients and reported excellent results from the entire cohort of its phase 2b open-label maintenance study in April this year. This interim analysis after one year once-daily treatment with 50mg obefazimod included all 217 patients who enrolled into the maintenance study and the data emphasizes the capacity of obefazimod to maintain and further improve patient outcomes over time, as well as its continued favorable safety and tolerability. During the induction and the maintenance phases of the 2b study, obefazimod continued to show a good tolerability profile, confirming the data already generated in over 1,000 patients and volunteers treated with obefazimod so far.

The initiation of the global phase 3 clinical program with obefazimod for the treatment of moderate to severe UC is on track and the "First-Patient-In" is scheduled for end of September 2022. In consultation with international regulators, including the US and European regulatory agencies (FDA and EMA), 25mg and 50mg will be investigated in phase 3 for both induction and subsequent maintenance in UC. Abivax is working with IQVIA, a global premier CRO, to jointly set-up and conduct these studies across Europe, the US, Japan and other global geographies.

Currently, more than 430 study sites, out of the targeted 600 sites, have already been qualified for the phase 3 trials.