Q32 Bio has announced positive 36-week topline results from Part B of its Phase 2 SIGNAL-AA clinical trial evaluating bempikibart, an investigational treatment for adults with severe to very severe alopecia areata (AA). Bempikibart is an investigational monoclonal antibody (biologic) that targets the IL-7 and TSLP pathways, two immune system signals believed to play a role in the development of alopecia areata. This is a different mechanism than JAK inhibitors (current U.S. Food and Drug Administration (FDA) approved treatments for severe AA). Bempikibart is administered subcutaneously. In the study, participants experienced a 35.3% average reduction in Severity of Alopecia Tool (SALT) scores after 36 weeks of treatment. Forty percent of participants (10 out of 25) in the modified intent-to-treat analysis achieved SALT 20, meaning they regained at least 80% scalp hair coverage. The treatment was generally well tolerated, with the most common side effect of mild injection-site reactions. Interestingly, researchers also reported early signs that some participants maintained or continued to improve their hair regrowth after stopping treatment, although longer follow-up is ongoing. Approximately one-third of participants in the study had previously been treated with an oral JAK inhibitor, suggesting bempikibart may have potential for people who have already tried existing therapies or are seeking an alternative to JAK inhibitors. Based on these findings, Q32 Bio plans to continue Part B of this Phase 2 trial through week 52 with full study results expected to be presented at a future medical meeting this year. Q32Bio also intends advance bempikibart into a registration-directed clinical development program in the first half of 2027. It’s important to remember that bempikibart is still an investigational therapy and has not been approved by the FDA. While these results are encouraging, additional clinical studies are needed to confirm its safety and effectiveness before it may become available to patients. NAAF will continue to monitor the progress of this and other investigational treatments and share updates as they become available. Read the press release View the webinar View the slides from the webinar
