Q32 Bio has reported positive 36-week top line data from Part B of the SIGNAL-AA Phase IIa trial of bempikibart for patients with severe or very severe alopecia areata (AA).
Bempikibart is a fully human antibody that targets the interleukin-7 receptor alpha (IL-7Rα) and is designed to modulate adaptive immune responses by blocking the IL-7 and thymic stromal lymphopoietin (TSLP) pathways.
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The trial enrolled 33 patients with severe or very severe forms of AA, most with baseline severity of alopecia tool (SALT) scores between 50 and 100.
Among the trial population, 36.4% had previously used oral janus kinase (JAK) inhibitor therapies. Patients received subcutaneous bempikibart over 36 weeks, beginning with four weekly loading doses of 200mg followed by dosing every other week.
The trial permitted enrolment of patients who had previous exposure to JAK inhibitors, and more patients were enrolled than originally planned due to demand.
Analysis focused on the mean percentage change from baseline in SALT score in the modified intent-to-treat (mITT) group at 36 weeks.
Findings showed a mean 35.3% reduction in SALT score in the mITT group. SALT-20 response, defined as at least 80% scalp hair coverage, was achieved by 40% of the mITT group and 30.3% of all enrolled patients.
SALT30 and SALT50 responses occurred in 44.0% of the mITT population, and in 33.3% using the intent-to-treat approach.
Q32 Bio CEO Jodie Morrison said: “Today’s Part B 36-week top line results mark a significant milestone for Q32 Bio, supporting our target efficacy and safety profile and providing compelling evidence reinforcing the therapeutic potential of bempikibart in alopecia areata.
“We believe these findings highlight the opportunity to deliver a differentiated, targeted treatment option for patients who remain in need of an effective, safe, and more durable alternative to JAK inhibitors.
“These results support advancement in alopecia areata and strengthen our conviction in bempikibart’s applicability across the broader autoimmune and inflammatory landscape.”
The company reported a generally well-tolerated safety profile in Part B, with no new safety signals and no treatment-related serious adverse events.
Off-drug follow-up through 52 weeks and open-label extension enrolment are ongoing.
Q32 Bio also completed an open-label extension for Part A of the trial, where bempikibart continued to show a well-tolerated safety profile.
The company anticipates advancing bempikibart into a registration-directed programme in the first half of 2027 and plans to share additional data at a future medical meeting.
