Q32 Bio Sets 2027 Registration Program For Bempikibart In Alopecia
(RTTNews) - Q32 Bio (QTTB) reported additional 36-week results and initial 16-week off-drug findings from Part B of the Phase 2a SIGNAL-AA trial of bempikibart in patients with severe or very severe alopecia areata.
The data were presented at the European Academy of Dermatology and Venereology Congress 2026.
Bempikibart is an investigational fully human anti-IL-7Ra antibody designed to block signaling by IL-7 and thymic stromal lymphopoietin (TSLP), with the goal of re-regulating adaptive immune function.
The candidate is being developed for severe and very severe alopecia areata.
36-week data show improvements in hair loss
Part B enrolled 33 patients with severe or very severe alopecia areata, defined by baseline SALT scores of 50 to 100.
Patients received subcutaneous bempikibart at 200 mg weekly for four loading doses, followed by 200 mg every two weeks for 32 weeks.
At Week 36, the mean reduction from baseline in SALT score was 35.3% in the modified intent-to-treat population.
SALT-20, SALT-30 and SALT-50 responses were observed in 40%, 44% and 44% of patients, respectively, in the mITT population.
Among patients with prior oral JAK inhibitor exposure, four previous JAK responders had a mean SALT reduction of 48.3%, compared with 4.8% among six previous JAK nonresponders. JAK inhibitor-naive patients had a mean SALT reduction of 44.1%.
Responses maintained after treatment
Q32 also reported initial 16-week off-drug results from 18 patients following completion of treatment. During the off-drug period, 44% of patients achieved SALT-20, while 61% and 50% achieved SALT-30 and SALT-50 responses, respectively.
Among 12 patients who had demonstrated hair growth by Week 36, all maintained their response without more than a 20-point worsening in SALT score during the initial off-drug period, while 42% further deepened their response.
The company said one patient with SALT-10 at Week 36 achieved complete hair regrowth, with a SALT score of zero, while two patients who had reached SALT-20 improved further to SALT-10.
Safety and biomarker findings Bempikibart was generally well tolerated, with no new safety signals reported. There were no serious or Grade 3 or higher treatment-related adverse events.
Injection-site reactions occurred in 36.3% of patients, representing 4% of all dose administrations. The reactions were mild, resolved without intervention and did not lead to treatment discontinuation.
Pharmacokinetic and pharmacodynamic analyses showed earlier achievement of steady-state exposure following the loading regimen, along with reductions in CD3-positive T-cell and Th1/Th2 biomarkers. Skin biopsy findings also showed reduced CD3-positive and CD8-positive immune-cell infiltration and increased anagen follicles.
Registration-directed program planned
Q32 Bio said it plans to advance bempikibart into a registration-directed development program for severe and very severe alopecia areata in the first half of 2027, subject to regulatory discussions.
The company is continuing an open-label extension study to evaluate longer-term treatment and potential maintenance dosing intervals. Additional extension data are expected in the second half of 2027.
QTTB has traded between $1.90 and $23.57 over the past year. Currently, QTTB is trading at $9.45, down 0.84%.
