Abivax SA (ABVX) on Monday announced topline results from ABTECT Maintenance Part 2, a supplemental portion of its Phase 3 ulcerative colitis maintenance program evaluating obefazimod in patients who did not respond to induction treatment or relapsed during the main maintenance trial.
Among induction non-responders, patients treated with 50 mg obefazimod achieved clinical remission of 37.2% and clinical response of 61.5% at Week 44, the company said.
Among patients who relapsed during Maintenance Part 1, re-treatment with 50 mg obefazimod achieved clinical response and remission rates of 69.7% and 45.0%, respectively, in those previously on placebo, according to the company.
The company said no new safety signals emerged from Part 2, with malignancy and non-melanoma skin cancer rates remaining within expected background ranges for ulcerative colitis patients.
Abivax said the results strengthen its confidence ahead of a planned new drug application submission later this year.