Q32 Bio reports Part B data for bempikibart in alopecia areata at EADV 2026
The company said 36-week and off-drug follow-up results support moving bempikibart into a registration-directed program targeted for the first half of 2027.
Q32 Bio Inc. announced on September 30, 2026 additional 36-week results and initial off-drug findings from Part B of the SIGNAL-AA Phase 2a trial testing bempikibart in patients with severe or very severe alopecia areata, presented in a late-breaking oral and poster session at the European Academy of Dermatology and Venereology Congress 2026.1 The company had previously announced topline results from this trial in July 2026.1
Part B enrolled 33 patients with severe or very severe AA and baseline SALT scores of 50-100, with a maximum current episode duration of four years; 36.4% of enrolled patients had prior oral JAK inhibitor treatment.1 Dosing consisted of an initial loading regimen of 200mg weekly for four doses followed by 200mg every-other-week over 32 weeks, administered subcutaneously.1
At Week 36, the mITT analysis showed a mean percent reduction in SALT score from baseline of 35.3%.1 SALT-20 response was achieved by 40.0% (10/25) of patients in the mITT analysis and 30.3% (10/33) in the ITT analysis.1 SALT30 and SALT50 responses were each reached by 44.0% (11/25) of mITT patients and 33.3% (11/33) of ITT patients.1
In the 16-week off-drug follow-up, 18 patients entered the period, with 44% achieving SALT-20, 61% SALT30, and 50% SALT50 responses at that time point.1 Among 12 patients who had shown hair growth by Week 36, maintenance of response occurred in 100% and deepening of response in 42%.1
On safety, the company said there were no serious adverse events or Grade 3 or higher treatment-related events, and the most common treatment-emergent event was injection site reaction at 36.3%.1
Q32 Bio said it intends to move bempikibart into a registration-directed program for patients with severe or very severe AA in the first half of 2027, contingent on regulatory discussions planned for the second half of 2026, and anticipates data from the Part B open-label extension in the second half of 2027.1
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