Q32 Bio reports alopecia treatment trial results
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- Q32 Bio reported positive 36-week Phase 2a SIGNAL-AA results for bempikibart in severe alopecia areata patients.
- The trial showed a mean 35.3% reduction in SALT score from baseline in the modified intent-to-treat population.
- Q32 Bio said the results support plans for a registration-directed program in the first half of 2027.
Q32 Bio (NASDAQ:QTTB) reported positive 36-week topline results from Part B of the Phase 2a SIGNAL-AA trial evaluating bempikibart in 33 patients with severe or very severe alopecia areata.
The study met its prespecified primary endpoint, showing a mean 35.3% reduction in Severity of Alopecia Tool (SALT) score from baseline in the modified intent-to-treat population.
At Week 36, 40% of modified intent-to-treat patients achieved a SALT-20 response, while 44% and 33.3% of patients reached SALT30 and SALT50 responses respectively across the modified intent-to-treat and intent-to-treat groups.
Q32 Bio reported that bempikibart showed a generally well-tolerated safety profile with no treatment-related serious adverse events or Grade 3 or higher events.
Bempikibart is an investigational antibody designed to regulate immune pathways involved in inflammatory diseases, including alopecia areata.
Q32 Bio said pharmacokinetic and anti-drug antibody data supported its loading-dose approach and that it plans to begin a registration-directed development program during the first half of 2027.