Abivax Updates UC Therapy Strategy, Announces Early Preclinical Data on Obefazimod and Etrasimod in IBD Mouse Model

Abivax Provides Update on Ulcerative Colitis (UC) Combination Therapy Program Strategy and Announces Early Preclinical Combination Data of Obefazimod and Etrasimod in Inflammatory Bowel Disease (IBD) Mouse Model

Abivax is actively conducting preclinical studies with multiple oral and injectable therapies and will report additional data in the fourth quarter of 2024. The pre-clinical evaluation of obefazimod combined with etrasimod demonstrated improved body weight protection and Disease Activity Index with a synergistic and statistically significant reduction of several cytokines (TNF-alpha, IL-17, IL-6, IFN-gamma) in the blood compared to each treatment alone.

Abivax SA, a clinical-stage biotechnology company focused on developing therapeutics that leverage the body’s natural regulatory mechanisms to stabilize immune response in patients with chronic inflammatory diseases, announced the results of initial preclinical combination data of obefazimod combined with etrasimod in a mouse model of IBD.

David Rubin, MD, Professor of Medicine and Chief of Gastroenterology, Hepatology, and Nutrition at The University of Chicago, highlighted the need for new combination therapies in IBD. He noted that despite advances in targeted therapies, less than half of patients achieve clinical remission, and many of those who do eventually lose their response. Exploring scientifically driven combination therapies is essential to surpass the existing efficacy ceiling and improve long-term patient outcomes.

Marc de Garidel, CEO of Abivax, stated that the goal is to develop a fixed-dose combination therapy for UC patients that offers best-in-disease state induction, maintenance efficacy, and a safety profile comparable to obefazimod. He noted that obefazimod’s promising safety and efficacy profile makes it an attractive candidate for combination with other mechanisms of action to overcome the current efficacy limitations observed with advanced therapies.

Fabio Cataldi, MD, Chief Medical Officer of Abivax, outlined the combination therapy program, which involves multiple stages. Initially, additional pre-clinical experiments will assess the efficacy of obefazimod in combination with other mechanisms of action. The aim is to select a candidate in 2025 and work towards developing a fixed-dose combination for clinical development.

Garidel expressed optimism about the promising data generated from the preclinical combination program and indicated plans to present this data at an upcoming scientific conference. The company is actively conducting further combination studies targeting various disease pathways and plans to provide an update on progress by year-end.

In the preclinical study, obefazimod was combined with etrasimod in the T-cell adoptive transfer mouse model. Male mice were intraperitoneally injected with CD4+CD45high or CD4+CD45low cells and treated orally for 55 days with obefazimod or etrasimod alone or in combination. The study results revealed that the combination treatment led to improved body weight protection and Disease Activity Index, with a synergistic and statistically significant reduction in several cytokines (TNF-alpha, IL-17, IL-6, IFN-gamma) in the blood compared to each drug alone.

Obefazimod, Abivax’s lead investigational drug candidate, is an orally administered small molecule that has shown potential in enhancing the expression of a single microRNA, miR-124. Positive Phase 2 clinical trial data in UC patients led to the initiation of a pivotal global Phase 3 clinical trial program, with the first patients enrolled in the US in October 2022. A Phase 2b clinical trial in Crohn’s disease is expected to commence in the third quarter of 2024, and exploration of potential combination therapy opportunities in UC is ongoing.

Abivax is a clinical-stage biotechnology company based in France and the United States, focused on developing therapeutics that utilize the body’s natural regulatory mechanisms to stabilize immune response in patients with chronic inflammatory diseases. The company’s lead drug candidate, obefazimod (ABX464), is currently in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis.