Roivant reports successful Phase 3 uveitis trials for brepocitinib
Roivant Sciences said on October 21 that brepocitinib met the main efficacy endpoint in its CLARITY-1 and CLARITY-2 Phase 3 studies for non-infectious uveitis. Among 371 participants receiving 45 mg once daily, median time until treatment failure exceeded 48 weeks with brepocitinib versus approximately 12 weeks with placebo, while pooled steroid-free quiescence at Week 48 was 62% versus 20%. Priovant Therapeutics, Roivant's subsidiary, plans to file a supplemental New Drug Application in the first half of 2027, and the reported safety profile showed no new signals.
Why it matters
The results give Roivant a basis to pursue a supplemental regulatory filing for brepocitinib in non-infectious uveitis. The company plans to discuss the potential commercial opportunity at an Investor Day scheduled for Dec. 9.
Key facts
- 1The CLARITY-1 and CLARITY-2 studies tested brepocitinib over 48 weeks, with the primary measure tracking treatment failure from Week 6 through Week 48 in 371 patients. investing.com
- 2At Week 48, treatment failure occurred in 35.4% of brepocitinib recipients versus 78.7% of placebo recipients in CLARITY-1, and in 32.4% versus 77.8% in CLARITY-2. investing.com
- 3Among participants who began the trials with macular edema, 42% of eyes treated with brepocitinib had resolved the condition at Week 48, compared with 4.8% with placebo. investing.com
- 4Three percent of participants stopped brepocitinib because of adverse events. investing.com
- 5Roivant shares rose 9% in premarket trading after the trial update. rttnews.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.