Abivax Announces Landmark Phase 3 ABTECT Maintenance Trial Results Evaluating Obefazimod in Moderately to Severely Active Ulcerative Colitis
Abivax reported positive Phase 3 maintenance trial results for obefazimod in ulcerative colitis, with both 25 mg and 50 mg doses meeting the primary endpoint of clinical remission at Week 44. The 25 mg dose achieved a 50.8% remission rate and the 50 mg dose 51.3%, compared to 10.4% for placebo, with p-values <0.0001. Both doses also met all key secondary endpoints, including endoscopic improvement and remission. The drug demonstrated a favorable safety profile with no new safety signals.
Key figures
- Drug Name
- obefazimod
- Phase Of Trial
- Phase 3
- P value
- <0.0001
- Trial population n
- 580
- Nd submission target
- Q4 2026
- Clinical remission 25mg
- 50.8%
- Clinical remission 50mg
- 51.3%
- Clinical remission placebo
- 10.4%
- Placebo adjusted delta 25mg
- 39.3%
- Placebo adjusted delta 50mg
- 40.3%
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