Waltham, Mass. — Q32 Bio reported new Phase 2a data showing bempikibart produced clinically meaningful improvements and durable responses in patients with severe or very severe alopecia areata.
The results came from Part B of the SIGNAL-AA study and were presented at the European Academy of Dermatology and Venereology Congress 2026. Bempikibart is a fully human anti-IL-7Rα antibody designed to block IL-7 and TSLP signaling and re-regulate adaptive immune function.
Q32 Bio said the drug demonstrated clinically meaningful efficacy across the primary and key secondary endpoints at week 36, while responses were maintained or deepened during a subsequent 16-week period in which patients received no treatment.
“We’re proud to share our compelling SIGNAL-AA Part B results with the scientific community in late-breaking oral and poster presentations at EADV,” said Jodie Morrison, Chief Executive Officer of Q32 Bio.
“We are committed to developing bempikibart as a highly differentiated, targeted treatment option for patients with alopecia areata and believe our Part B results demonstrate meaningful progress on that commitment,” Morrison added.
Part B enrolled 33 patients with severe or very severe alopecia areata. Patients received bempikibart for 36 weeks, followed by a 16-week off-drug period through week 52. About 36% of enrolled patients had previously received oral JAK inhibitor therapy.
At week 36, patients in the modified intent-to-treat population had a mean 35.3% reduction from baseline in Severity of Alopecia Tool, or SALT, scores.
Q32 Bio said 40% of patients in the modified intent-to-treat group achieved a SALT-20 response, while 44% achieved SALT30 and 44% achieved SALT50 responses. In the full intent-to-treat population, 30.3% achieved SALT-20 and 33.3% achieved both SALT30 and SALT50.
Among patients who previously responded to JAK inhibitors, the mean reduction in SALT score was 48.3%, compared with 4.8% among previous JAK inhibitor non-responders. JAK inhibitor-naïve patients had a 44.1% mean reduction.
During the 16-week off-drug period, 44% of patients achieved a SALT-20 response, 61% achieved SALT30 and 50% achieved SALT50. Among 12 patients who showed hair growth by the end of the treatment period, all maintained their response and 42% experienced further improvement.
“We are excited to show once again that bempikibart was able to induce deep, durable responses in severe and very severe alopecia areata,” said José Trevejo, M.D., Ph.D., Chief Medical Officer of Q32 Bio.
“We believe these data support a less frequent, chronic maintenance dosing regimen once patients respond. We look forward to exploring a potential maintenance regimen in our open-label extensions as we move rapidly into registrational studies in the first half of 2027,” Trevejo added.
Q32 Bio also reported biomarker and biopsy findings supporting bempikibart’s mechanism of action, including reductions in inflammatory biomarkers and immune-cell infiltration around hair follicles. The company said no meaningful anti-drug antibody impact on pharmacokinetics was observed.
The company said bempikibart was generally well tolerated, with no new safety signals identified, and plans to advance the drug into a registration-directed program for alopecia areata in the first half of 2027.
