Q32 Bio Inc. announced on April 16, 2025, that it has dosed the first patients in both the Part A open-label extension (OLE) and Part B of the SIGNAL-AA Phase 2a clinical trial evaluating bempikibart in patients with severe and very severe alopecia areata (AA). This milestone reflects ongoing momentum in the clinical development of bempikibart and marks a significant step forward for the program.
The Part A OLE was initiated based on re-consent rates and strong patient demand for continued dosing after the completion of Part A, where continued responses were observed in multiple patients through week 55, approximately seven months post last dose. Part B is an open-label clinical trial dosing approximately 20 evaluable patients for 36 weeks, with follow-up out to 52 weeks.
Part B will include an initial loading regimen of 200mg of bempikibart dosed weekly over four weeks, followed by a maintenance dose of 200mg every-other-week for 32 weeks. The trial is intended to support advancement into pivotal trials upon completion, pending review of the results. Q32 Bio expects to report topline data from SIGNAL-AA Part B in the first half of 2026.
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