Clinical TrialJul 13, 2026, 08:46 AM
Q32 Bio Bempikibart Phase 2a AA Trial Shows 35.3% SALT Reduction
AI Summary
Q32 Bio Inc. announced positive topline results from Part B of its SIGNAL-AA Phase 2a clinical trial for bempikibart (ADX-914) in patients with alopecia areata (AA). The trial demonstrated robust clinical activity with a 35.3% mean reduction in SALT score at Week 36 in the mITT population, and 40.0% of patients achieved SALT-20. Bempikibart showed a favorable safety profile with no Grade 3 or higher adverse events, supporting its advancement into a registration-directed program.
Key Highlights
- Bempikibart achieved 35.3% mean SALT score reduction at Week 36 (mITT population).
- 40.0% of mITT patients achieved SALT-20 at Week 36.
- The trial reported no Grade 3 or higher adverse events.
- Injection site reaction incidence was low at 4% across all Part B dose administrations.
- Results support advancing bempikibart into a registration-directed program for severe/very severe AA.
- Q32 Bio plans to engage with the FDA and initiate registrational trials in 1H27.
- Development plans for adolescent and moderate alopecia areata are also underway.
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