Key Takeaways
Abivax SA reported that 68% of ulcerative colitis patients in a long-term study remained in clinical remission at 144 weeks on a reduced 25mg dose of its lead drug, obefazimod, alongside its first-quarter financial results.
"The durability of clinical remission observed for up to seven years, together with the favorable tolerability profile observed to date, supports the potential of obefazimod as a durable treatment option for people living with ulcerative colitis,” Fabio Cataldi, MD, Chief Medical Officer of Abivax, said in a statement.
The French biotech company ended the first quarter with €491.6 million in cash, cash equivalents and short-term investments, which it projects provides a cash runway into the fourth quarter of 2027. The Q1 net loss narrowed to €48.5 million from €52.4 million a year earlier, while the operating loss widened to €56.2 million from €47.2 million due to increased research and development spending.
Abivax is now focused on its upcoming Phase 3 ABTECT maintenance trial results in late Q2 2026. The data is a critical catalyst for a planned New Drug Application submission to the US Food and Drug Administration in the fourth quarter of 2026, which could position obefazimod against competitors like Pfizer's Velsipity and Bristol Myers Squibb's Zeposia.
The interim data comes from the company's Study 108, a Phase 2a/2b open-label extension trial. In the study, 130 patients who had previously been treated with a 50mg daily dose of obefazimod for two to four years were de-escalated to a 25mg maintenance dose. After 144 weeks on the lower dose, 68% (88 of 130) of patients in the intent-to-treat population remained in clinical remission. The company also noted that 80% of participants completed the 144-week evaluation and no new safety signals were observed.
First-quarter financials showed a significant ramp-up in spending as the company prepares for potential commercialization and explores new indications for obefazimod. Research and development expenses climbed 26% to €49.5 million from €39.3 million in the year-ago quarter. Sales and marketing costs nearly doubled to €1.7 million.
The company also has key data approaching for another indication. Abivax expects to report topline results from its Phase 2b induction trial of obefazimod for Crohn’s disease in the fourth quarter of 2026.
The sustained remission on a lower dose strengthens obefazimod's profile as a long-term maintenance therapy, a crucial factor for commercial success in the chronic inflammatory disease market. Investors are now awaiting the pivotal Phase 3 maintenance data in late Q2, which will determine the viability of the planned Q4 regulatory filing.
This article is for informational purposes only and does not constitute investment advice.
