Abivax has reported that the Phase III ABTECT maintenance trial of obefazimod, its investigational oral, first-in-class miR-124 enhancer, met the primary endpoint in adults with moderately to severely active ulcerative colitis (UC).
The double-blind, global, multi-centre, placebo-controlled, randomised trial assessed the efficacy of both 25mg and 50mg doses of obefazimod in achieving clinical remission and all key secondary endpoints at week 44.
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Adult participants showing clinical response following the eight-week ABTECT-1 and ABTECT-2 induction trials were re-randomised to obefazimod or placebo.
The results demonstrated that obefazimod met the US Food and Drug and Administration (FDA) primary endpoint of placebo-adjusted clinical remission at week 44, with a 39.3% difference for 25mg and a 40.3% difference for 50mg.
The placebo clinical remission rate was 10.4%, noted as the lowest reported to date in a Phase III UC maintenance responder re-randomisation study.
Both obefazimod doses met all key secondary endpoints, including endoscopic improvement, endoscopic remission, HEMI1, corticosteroid-free clinical remission, and sustained clinical remission.
Efficacy was confirmed across multiple measures of disease control. Safety profile analysis revealed no new safety signals, and treatment was generally well tolerated.
Abivax plans to submit a new drug application to the FDA in late fourth quarter 2026.
Abivax CEO Marc de Garidel said: “Today’s landmark Phase III results highlight the exceptional potential of obefazimod to redefine the treatment landscape for UC. With its compelling, durable efficacy and favourable safety profile, combined with the convenience of a once-daily oral treatment, obefazimod has the potential to transform UC patient care.”
The trial also showed that there were cancer cases among patients who were administered the higher dose of the medicine.
The company noted that one reported case each of prostate, breast, and colon cancers were regarded by investigators as unrelated to the treatment, and no specific clustering of organs was noted.
Out of the four non-melanoma skin cancer (NMSC) cases on the 50mg dose, two were considered by investigators to be not or unlikely related to the drug; among the other two cases, one had a prior medical history of skin cancer.
The average age of the NMSC cases observed was 62 years, in contrast to 42 years in the overall trial population, which aligns with the age-related risk for NMSC.
