Obefazimod for Ulcerative Colitis

Potent Anti-Inflammatory

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Obefazimod is an oral, first-in-class, small molecule that has demonstrated safety and profound anti-inflammatory activity in preclinical trials and in Phase 2a and Phase 2b induction trials to treat ulcerative colitis (UC). Patients who completed the induction studies had the option to roll over into the respective open-label extension studies.
In May and September 2021, Abivax communicated the top-line and full results, respectively, of its randomized, double-blind and placebo-controlled Phase 2b trial conducted in 15 European countries, the US and Canada in 254 patients. The primary endpoint (statistically significant reduction of Modified Mayo Score) was met with once-daily administration of obefazimod (25mg, 50mg, 100mg) at week 8.

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.

In addition to the induction results, an interim analysis of the maintenance study demonstrates best-in-class clinical remission in 55.3% of 217 ulcerative colitis (UC) patients after 48 weeks of once-daily oral administration of 50mg obefazimod. Moreover, in the subgroup of patients who had at least a clinical response after the 8-week induction study (n=121), 65.3% achieved clinical remission during the first year of maintenance treatment.

To date, over 1,000 patients have been treated with obefazimod, including those who have been on continuous daily dosing for more than three years. Based on our observations and, in comparison with currently available therapeutic options, obefazimod shows a very good clinical safety and tolerability profile along with evidence of superior long-term efficacy.

Because of its ability to greatly upregulate the production of a unique RNA splicing product and anti-inflammatory agent, miR-124, the mechanism of action of obefazimod is unique and has shown promise in clinical trials in its ability to bring patients into remission and heal inflammatory lesions in UC.

Durable efficacy

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 subsequent open-label maintenance study to evaluate the long-term safety and efficacy profile of obefazimod for up to two years.

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Among the 217 patients who completed the first year of 50mg once-daily oral dosing with obefazimod (or who dropped out), 52 had entered the maintenance study already in clinical remission. 38 (73.1%) out of these 52 patients stayed in clinical remission during this first year of maintenance treatment.

It is remarkable that 82/165 (49.7%) patients who were not in clinical remission at the end of induction achieved a de novo clinical remission during the first year of maintenance.

Furthermore, the clinical remission rate for patients who did not show at least a clinical response at the end of the induction phase was 42.7% (full analysis set) after 48 weeks of treatment, demonstrating that long-term administration of obefazimod provided substantial clinical benefits also for these patients.

In addition to the phase 2b maintenance results, Abivax 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 administration of obefazimod 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).

The phase 2b induction trial and 48-week extension results of obefazimod in UC were published in the prestigious, peer-reviewed journal “The Lancet Gastroenterology and Hepatology” with the title “ABX464 (obefazimod) for moderate to severe active ulcerative colitis: a randomised, placebo controlled phase 2b induction trial and 48 week, open-label extension“.

Obefazimod Mechanism of Action in Ulcerative Colitis

Phase 3 clinical program

1,200 moderate to severe UC patients across 36 countries will take part in the pivotal phase 3 program which consists of two induction studies and a subsequent maintenance study (ABTECT-1 and ABTECT-2 induction trials – ABX464-105 and ABX464-106 – and ABTECT maintenance trial – ABX464-107). These three pivotal studies are all randomized, double-blind and placebo controlled, using independent and central review of the video-taped endoscopies. The primary efficacy endpoint assessed at week 8 (induction) and at week 44 (maintenance) will be clinical remission according to the modified Mayo Score, as required by FDA.

In consultation with international regulators, including FDA and EMA, obefazimod 25mg and 50mg will be investigated in phase 3 for the treatment of UC in advanced therapies (AT) naïve and in AT-failure patients to support the future submission of marketing authorizations.