Abivax SA has confirmed plans to submit a new drug application for obefazimod, its candidate product for ulcerative colitis, to the US Food and Drug Administration late in the fourth quarter. This follows results from a Phase 3 trial that showed strong efficacy. The small molecule drug upregulates a microRNA known as miR124 in order to stabilise the immune response in patients with ulcerative colitis, a disease that affects the colon.
The Phase 3 maintenance trial, ABTECT, was a 44-week placebo-controlled study that evaluated the long-term efficacy and safety of obefazimod at 25 mg and 50 mg once daily in adults with moderate to severely active disease. Individuals who responded to two earlier obefazimod studies were re-randomised to the maintenance trial. Results from the trial showed that obefazimod met the primary endpoint of a placebo-adjusted clinical remission at week 44 in both dosage groups. The trial also recorded a 10.4% placebo clinical remission rate, the lowest reported to date in a Phase 3 ulcerative colitis maintenance responder re-randomisation trial.
The company said obefazimod demonstrated a favourable safety profile, but noted that there were a small number of reported skin cancer cases and other malignancy signals in the higher-dose group. It said investigators considered that the three malignancy signals were unrelated to the treatment, adding that no organ-specific clustering was observed. Separately, one of the skin cancer events occurred in a person with a history of skin cancer.
Furthermore, the mean age of the individuals with skin cancer events was 62 years compared with 42 years in the overall trial population. The safety data received a mixed reaction from share analysts, driving Abivax’s price down on both the Euronext Paris and US Nasdaq markets on 2 June.
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