Q32 Bio reports positive SIGNAL-AA Part B bempikibart results in alopecia areata

Q32 Bio Inc.

Bempikibart achieved 35.3% mean SALT reduction at Week 36 in mITT; SALT-20 was 40.0% (10/25) mITT and 30.3% (10/33) ITT in severe/very severe alopecia areata.
SALT 30 and SALT 50 responses each reached 44.0% (11/25) in mITT and 33.3% (11/33) in ITT at Week 36.
In the 16-week off-drug period, 18 patients entered; SALT-20 was 44%, SALT 30 was 61%, SALT 50 was 50%; maintenance occurred in 100% of 12 Week 36 responders and deepening in 42%.
Prior oral JAKi responders had 48.3% mean SALT reduction vs 4.8% for non-responders; JAK-naive patients had 44.1%.
Safety: no serious or Grade 3+ treatment-related AEs; most common TEAE was injection site reaction at 36.3%, all mild; Q32 plans registration-directed AA program in H1 2027.

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