Q32 Bio Begins Dosing in SIGNAL-AA Phase 2a Trial for Alopecia Areata

Q32 Bio Inc., a biotechnology firm based in Waltham, Massachusetts, has announced significant progress in its quest to develop a novel treatment for alopecia areata, a challenging autoimmune condition. The company has initiated patient dosing in both Part A's open-label extension (OLE) and Part B of the SIGNAL-AA Phase 2a clinical trial for a drug known as bempikibart. This development marks a crucial step forward in the clinical evaluation of bempikibart as a potential therapy for those suffering from this condition.

Jodie Morrison, the CEO of Q32 Bio, emphasized the promising outcomes observed so far. According to Morrison, the clinical data indicates that bempikibart, characterized by strong pharmacologic activity and a favorable safety profile, could potentially revolutionize the treatment landscape for alopecia areata. The drug has shown sustained efficacy in patient follow-ups conducted months after the completion of treatment, suggesting it could be a differentiated therapeutic option if it receives approval.

Earlier findings from Part A of the trial, which was a rigorous double-blind, placebo-controlled study across multiple centers, showcased encouraging results. The trial evaluated bempikibart in adult patients with severe to very severe alopecia areata over a 24-week treatment period, with follow-up extending to 36 weeks. The outcomes revealed improvements in the Severity of Alopecia Tool (SALT) scores and meaningful achievements in SALT-20 responses by the 36-week mark. Furthermore, post-trial data indicated lasting benefits up to 55 weeks, hinting at a potential long-lasting effect and distinguishing bempikibart from existing therapies. Due to positive patient feedback and a high re-consent rate, Q32 Bio has initiated an OLE for participants who completed Part A, allowing extended monitoring.

Part B of the SIGNAL-AA Phase 2a trial is designed as an open-label study. It aims to administer bempikibart to around 20 patients with severe forms of alopecia areata over 36 weeks, followed by a 52-week observation period. The regimen involves an initial dose of 200mg weekly for four weeks, transitioning to a maintenance dose every other week for the remaining 32 weeks. Efficacy assessments will focus on changes in SALT scores and achieving specific SALT benchmarks by the end of the dosing period, with continued evaluation through the follow-up phase. If successful, this trial may pave the way for pivotal studies, contingent on a thorough analysis of the results. Q32 Bio is on track to release the topline data from Part B in the first half of 2026.

Q32 Bio is at the forefront of targeting key regulators of the adaptive immune system to restore immune balance, focusing on treatments for autoimmune diseases like alopecia areata, which affects approximately 700,000 individuals in the United States and currently has limited treatment options. The company's flagship candidate, bempikibart, is a fully human antibody targeting the IL-7Rα pathway, which plays a role in multiple autoimmune conditions. By intervening in these pathways, Q32 Bio aims to modify disease processes associated with T-cell mediated responses. The company continues to advance its Phase 2 program, positioning bempikibart as a promising candidate in the fight against alopecia areata and beyond.