France-based Abivax announced on 22 July that its oral miRNA modulator obefazimod (ABX464) met primary endpoints in two Phase III trials (ABTECT-1 and ABTECT-2) for moderate-to-severe ulcerative colitis (UC). The drug, which enhances anti-inflammatory miR-124 expression, achieved clinical remission in 23.8% (25 mg) and 21.7% (50 mg) of patients at week 8 versus 2.5% for placebo in ABTECT-1 (n=425), with similar efficacy trends in ABTECT-2 (n=850). Endoscopic improvement rates reached 37.5% (25 mg) and 33.3% (50 mg) in ABTECT-1.

The trials represent the largest UC Phase III program to date, including the highest proportion of Janus kinase (JAK) inhibitor-refractory patients. Obefazimod maintained a consistent safety profile with no new signals. Abivax will continue 44-week maintenance studies in 678 responders, with data expected in Q2 2026 to support regulatory filings. The first-in-class mechanism addresses unmet needs in UC, where 40-60% of patients fail biologic therapies.

According to PharmCube's NextBiopharm® database, obefazimod is Abivax's lead candidate after it launched its only marketed product, a hepatitis B vaccine, in 2015. Click here to request a free trial for NextBiopharm®.