Core Insights - Bempikibart shows promising results in reducing SALT scores in patients with severe alopecia areata, indicating potential for long-term efficacy and safety [1][3][4] Clinical Trial Results - In the Phase 2a clinical trial, bempikibart demonstrated a mean reduction in SALT score of 16% at week 24 compared to a 2% reduction in the placebo group, with a p-value of 0.045 [5][6] - At week 36, patients treated with bempikibart exhibited a mean SALT score reduction of 20%, with a 28% reduction observed in patients with severe disease [7][12] - The trial included 41 patients, with a primary endpoint focused on the mean relative percent change in SALT score at 24 weeks [4] Safety and Tolerability - Bempikibart was well-tolerated, with no Grade 3 or higher adverse events reported, and no related viral infections in the treatment group [8][9] Mechanism of Action - Bempikibart acts as a potent inhibitor of IL-7 and TSLP, leading to significant reductions in Th2 biomarkers and modulation of T-cells [9][10] Future Development Plans - Q32 Bio plans to initiate an open-label extension study in the first half of 2025, along with the SIGNAL-AA Part B trial, which will include a loading dosing regimen [2][14][15] - Topline data from SIGNAL-AA Part B is expected in the first half of 2026, supporting advancement into pivotal trials [2][15]
Q32 Bio Presents Results from SIGNAL-AA Part A Clinical Trial Evaluating Bempikibart in Patients with Alopecia Areata at the 2025 American Academy of Dermatology Meeting