Q32 Bio Announces Completion of Enrollment in Part B of SIGNAL-AA Phase 2a Clinical Trial of Bempikibart for Alopecia Areata

Core Insights - Q32 Bio has completed enrollment in Part B of the SIGNAL-AA Phase 2a clinical trial for bempikibart, exceeding the initial target of approximately 20 patients, with a total of 33 patients enrolled due to high demand [1][3] - Bempikibart is a fully human anti-IL-7R antibody aimed at treating severe alopecia areata (AA) by re-regulating adaptive immune function [1][3] - The trial is designed to evaluate the efficacy of bempikibart over a 36-week treatment period, with follow-up extending to 52 weeks, and aims to support advancement into pivotal trials based on the results [2][3] Company Overview - Q32 Bio is a clinical stage biotechnology company focused on developing therapies for alopecia areata and other autoimmune diseases, targeting the adaptive immune system [3] - Approximately 700,000 individuals in the United States are affected by alopecia areata, highlighting the need for new treatment options [3] Clinical Trial Details - Part B of the SIGNAL-AA trial includes a loading regimen of 200mg of bempikibart administered weekly for four doses, followed by a maintenance dose every other week for a total of 36 weeks [2] - Efficacy will be assessed using the Severity of Alopecia Tool (SALT) scores, with the goal of observing significant improvements in patients' conditions [2] Future Expectations - Preliminary data from early-enrolling patients in Part B indicate emerging signs of clinical activity, with a faster achievement of steady-state drug concentration compared to Part A [2] - Q32 Bio anticipates reporting topline data from Part B in mid-2026, which could lead to further development of bempikibart pending positive results [3]