Abivax Reports Positive 2-Year Interim Analysis of Obefazimod in Ulcerative Colitis

Abivax has announced promising interim results from a long-term study evaluating the effectiveness and safety of a reduced dose of obefazimod, a treatment for moderate to severe ulcerative colitis (UC). The study analyzed data from patients who continued treatment with a 25 mg daily dose of obefazimod after initially receiving a 50 mg dose in preceding Phase 2a and Phase 2b studies.

The findings indicate that patients maintained clinical remission at weeks 48 and 96, demonstrating the potential of obefazimod as a viable long-term treatment for UC. According to Marla Dubinsky, MD, a Co-Director at the Icahn School of Medicine at Mount Sinai, the ability to maintain remission with a lower dose provides clinicians with a valuable option for treatment de-escalation.

The open-label maintenance study included 130 patients who met the eligibility criteria (Mayo Endoscopic Subscore = 0 or 1). As of the data cut-off date of September 11, 2024, 113 patients had been evaluated at 48 weeks and 74 patients at 96 weeks. At the start of the study, 89% of the participants were in clinical remission. By week 48, 84% of evaluated patients remained in clinical remission, and by week 96, this figure was 87%. Similarly, symptomatic remission was observed in 92% of patients at baseline, sustaining at 91% and 92% at weeks 48 and 96, respectively.

These results also extended to other efficacy analyses, reinforcing the drug's potential. Silvio Danese, MD, from the San Raffaele University in Milan, highlighted the significant need for an oral UC treatment that is both well-tolerated and effective over the long term, expressing optimism about the findings.

The safety profile of obefazimod was consistent with previous studies, with no new safety concerns identified. Patient retention was high throughout the study, with only a small percentage discontinuing the treatment in the first and second years.

Fabio Cataldi, MD, Chief Medical Officer of Abivax, emphasized the promising nature of these results, which support the potential of obefazimod as a treatment for UC. The company anticipates presenting these findings at an upcoming medical meeting.

Obefazimod, Abivax’s leading investigational drug, is designed to enhance the expression of microRNA miR-124. Phase 2 trials have already shown positive outcomes, prompting the initiation of a global Phase 3 clinical trial program (ABTECT Program) in October 2022 in the United States. Additionally, a Phase 2b clinical trial for Crohn’s disease is expected to start in the fourth quarter of 2024, with ongoing exploration of combination therapy opportunities for UC.

Abivax is a biotechnology company focused on developing treatments that leverage the body's natural mechanisms to regulate immune responses in chronic inflammatory diseases. The company operates out of France and the United States, with obefazimod currently in Phase 3 trials for moderate to severe UC. These promising interim results further bolster the potential of obefazimod as a significant therapeutic option for UC.