Credit: Business Wire

New data from Abivax SA show 50 mg obefazimod, a small molecule that selectively upregulates miR-124 in immune cells, has resulted in clinical remission, as well as endoscopic remission for the majority of patients with ulcerative colitis.¹

The company released the results from the phase 2b open-label maintenance study that included 164 patients who completed the second year of once-daily oral 50 mg obefazimod.

“These two-year maintenance results are a strong confirmation of obefazimod’s potential to swiftly induce and, more importantly, maintain long-term efficacy in patients with moderate to severe ulcerative colitis,” Hartmut J. Ehrlich, MD, CEO of Abivax, said in a statement.

The Study

In the preceding induction study, the investigators found the safety and tolerability profile was consistent with previous findings, with no new safety signals identified.

The study included 254 patients with moderate to severely active ulcerative colitis who were placed into either a once-daily oral obefazimod treatment groups (25mg, 50mg and 100mg) cohort or placebo. Half of the patients had an inadequate response, a loss of response, or intolerance to biologics and/or JAK inhibitor treatments. The remaining 50% were refractory to conventional treatments.

The baseline disease characteristics were well balanced between all groups.

Patients with longstanding ulcerative colitis with a mean disease duration of 8.05 yearsand 71.4% of patients had a severe disease profile.

In the maintenance study, 97.7% (n = 217) of patients who completed the phase 2b induction study, regardless of treatments or treatment outcome, were enrolled to evaluate the long-term safety and efficacy profile of the treatment for up to 2 years. The results show 52.5% (n = 114) of patients achieved clinical remission at week 96, while 59.0% (n = 128) saw endoscopic improvement, 35.9% (n = 78) achieved endoscopic remission, and 70.5% (n = 153) achieved a clinical response.

On the other hand, 30 patients dropped out during the first year, 6 patients did not qualify for the second year of treatment because of a non-response after the first year, and 17 patients dropped out during the second year.

In safety data released in 2022, headaches were the most frequently reported adverse event, occurring in 30% (n = 19) of the 50 mg group, 21% (n = 13) of the 25 mg group, and 8% (n = 5) of the placebo group. In addition, severe headaches of a grade 3 or higher was reported in 5% (n = 3) of patients in the ABX464 group 100 mg group, 3% (n = 2) of the ABX464 50 mg group, 2% (n = 1) of the ABX464 25 mg group, and none in the placebo group.²

“Patients suffering from chronic inflammatory diseases, such as UC, often struggle to find a long-term effective treatment,” Sheldon Sloan, MD, M. Bioethics, CMO of Abivax, said in the statement.

“The existing high unmet medical need results from the significant proportion of UC patients who stop responding to currently available therapies within the first year of treatment, or who do not respond at all. Therefore, at Abivax, we want to make our drug-candidate obefazimod available as quickly as possible to patients suffering from ulcerative colitis and we believe that it has the potential to make a real difference to control the disease in the long run.”

References:

1. Press releases. Abivax. (2022, August 18). Retrieved April 19, 2023, from https://www.abivax.com/press-releases/