Abivax shares climbed about 27% in Tradegate trading on Monday after the French biotechnology company disclosed additional positive results from its ulcerative colitis trial involving obefazimod. Tradegate is a European after-hours trading platform where the move was recorded.
The firm reported that among patients who did not respond to an initial induction course of obefazimod, 37.2% achieved clinical remission after continued treatment at a 50 milligram dose by week 44. Endoscopic remission was observed in 34.5% of that patient group.
Abivax also provided data for patients who experienced relapse during the first portion of the maintenance phase. In those cases, increasing the obefazimod dose to 50 mg recaptured clinical remission in 45.5% of patients.
Earlier results from the same trial, released on June 1, were reiterated alongside the new figures. Those prior data showed that 50.8% of patients receiving a 25 mg dose and 51.3% of patients on a 50 mg dose achieved clinical remission, compared with 10.4% in the placebo arm.
Obefazimod is administered orally and is reported to act by raising levels of a small regulatory molecule, microRNA miR-124, which in turn dampens the body's inflammatory response.
Following the release of these results, Abivax confirmed plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration in the fourth quarter of this year.
The dataset highlighted by the company includes outcomes for patients who initially failed to respond to treatment, those who relapsed during maintenance, and dose-specific remission rates reported earlier in the trial. Market reaction on Tradegate reflected investor focus on how the new information pertains to the drug's potential efficacy across different patient subgroups.
While the company reported a notable share-price reaction and provided a timetable for regulatory filing, the published results are limited to the figures released and the firm’s stated FDA submission plans.
Contextual note - The article presents the trial outcomes as disclosed by Abivax and the company’s regulatory filing intention. No additional data, outcomes, or predictions beyond those statements are included.