Q32 Bio Inc. presented additional results from Part A of its SIGNAL-AA Phase 2a clinical trial of bempikibart in patients with severe and very severe alopecia areata (AA) at the 2025 American Academy of Dermatology (AAD) Meeting on March 8, 2025. The late-breaking oral presentation highlighted encouraging clinical activity, including improvement on SALT reduction at week 24 and continued effects after dosing cessation. Durable, ongoing responses were observed in multiple patients through week 36 and beyond to week 55, despite only 24 weeks of dosing.
The data suggests a potential for a remittive effect and durability of response, which Q32 Bio believes differentiates bempikibart from currently approved therapies. Bempikibart demonstrated a well-tolerated safety and tolerability profile, with no Grade 3 or higher adverse events related to treatment and no related viral infections reported. Pharmacokinetics supported subcutaneous dosing, and receptor occupancy data showed desired target engagement.
Clinical biomarkers indicated substantial reductions in Th2 biomarkers, including TARC, IgE, and eosinophils, and expected on-mechanism changes in T-cells, indicative of potent IL-7 and TSLP inhibition. Q32 Bio plans to initiate an open-label extension (OLE) and SIGNAL-AA Part B in the first half of 2025, with Part B topline data expected in the first half of 2026. The Part B trial will include an initial loading regimen and a longer dosing period.
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