Abivax reports excellent one-year efficacy and safety data of ABX464 phase 2b maintenance trial in ulcerative colitis

• Interim analysis demonstrates best-in-class clinical remission in 55.3% of 217 ulcerative colitis (UC) patients (full analysis set) after 48 weeks of once-daily oral 50mg ABX464
• 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 (full analysis set)
• Endoscopic improvement and endoscopic remission at week 48 achieved by 61.8% and 33.6% of the patients respectively (full analysis set)
• Good safety and tolerability profile supports chronic use of ABX464
• Final preparations to launch ABX464 global pivotal phase 3 clinical program in UC ongoing, inclusion of first patients is expected in Q3 2022

PARIS, France, April 06, 2022 – 6:00 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, today reports excellent results from the Interim Analysis of its phase 2b open-label maintenance study, including 217 patients who completed the one year of once-daily oral treatment with 50mg ABX464. These data emphasize ABX464’s capacity to maintain and further improve patient-outcomes over time, as well as its continued favorable safety and tolerability.

Prof. William Sandborn, M.D., University of California San Diego School of Medicine and Co-Founder and Chief Medical Officer at Shoreline Biosciences, CA, said: “The data of these patients treated for one year in this phase 2b maintenance study confirm the previous, positive observations made with ABX464 in the phase 2a. Currently, many patients stop responding or do not respond at all to available therapies. These results are encouraging as they suggest that ABX464 can induce short-term and, more importantly, maintain and even improve long-term efficacy in patients with in moderate to severe ulcerative colitis. The good safety and tolerability profile seen in the phase 2b is also very encouraging.”

Prof. Bruce Sands, M.D., M.S., the Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai, New York City, NY, added[1]: “These maintenance data indicate that ABX464 may change the treatment paradigm for bio-naïve as well as refractory ulcerative colitis patients. ABX464 showed a solid and durable efficacy signal along with a good tolerability profile, which differentiates it from many other products on the market or in late-stage testing in UC. Beyond efficacy and safety, ABX464 also offers convenient once-daily oral administration.”

Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, said: “We are very pleased with the results of the phase 2b maintenance study with ABX464 after the first year of continued daily treatment. 65.3% of patients with at least a clinical response at the end of induction were in clinical remission after one year, which confirms the outcome of the phase 2a study with 66.7%. These are best-in-class results, demonstrating that the unique mechanism of action of our drug-candidate can induce high rates of durable clinical remissions in patients suffering from moderate to severe ulcerative colitis. Along with the maintenance data recently reported from our phase 2a trial in rheumatoid arthritis, these results further underpin the capacity of ABX464 to effectively address a broad range of chronic inflammatory diseases. Abivax will be initiating the ABX464 phase 3 program in UC soon, with a first patient to be included in Q3 2022. We want to make this potentially transformative drug-candidate available as quickly as possible to patients suffering from ulcerative colitis and possibly further chronic inflammatory indications.”

Read the full press release on the Abivax website.