#United States #Waltham #Q32 Bio #Bempikibart #Alopecia Areata

Q32 Bio Completes Enrollment in Part B of SIGNAL-AA

Q32 Bio Inc., a clinical-stage biotechnology firm focused on groundbreaking therapies for alopecia areata (AA) and other immune-related conditions, has announced the successful completion of enrollment for Part B of the SIGNAL-AA Phase 2a clinical trial. This trial is investigating Bempikibart, a fully human monoclonal antibody that targets the IL-7Rα receptor. The company exceeded its initial target enrollment of 20 patients, reaching a total of 33 participants due to significant demand from both patients and healthcare professionals.

In a recent statement, Jodie Morrison, CEO of Q32 Bio, expressed satisfaction with the ability to surpass the enrollment goal, indicating a strong interest and confidence in Bempikibart's capability as a treatment for alopecia areata. Part A of the SIGNAL-AA trial already showcased promising outcomes, presenting Bempikibart as well-tolerated with impressive levels of clinical activity. Treatments involving Bempikibart function by blocking IL-7 and TSLP signaling pathways which are critical in regulating immune responses.

The SIGNAL-AA Phase 2a Clinical Trial

Part B of the trial will employ a loading regimen of 200mg of Bempikibart administered weekly for four doses, followed by a bi-weekly maintenance dose of the same amount for a total of 36 weeks, and a follow-up extending to 52 weeks. The main objective of this stage is to evaluate efficacy through the mean percentage change from baseline in the Severity of Alopecia Tool (SALT) scores, alongside the proportion of subjects achieving critical SALT improvements by week 36. This second phase aims to build upon the favorable findings from Part A as Q32 Bio advances Bempikibart towards pivotal trial phases pending positive results.

Preliminary indications of clinical efficacy are already emerging from the early participants in Part B. Furthermore, initial pharmacokinetic analyses reveal that patients reach the steady-state concentration of the drug approximately nine weeks sooner than those in Part A, which may suggest a quicker response due to the inclusion of the loading dose regimen.

With the total enrollment of 33 patients, significantly driven by interest from both patients and their treating physicians, Q32 Bio now anticipates releasing topline data for Part B in mid-2026. Ms. Morrison reiterated the necessity for patients suffering from alopecia areata to have access to new, safe, and durable treatment options beyond currently available therapies, emphasizing Q32 Bio's commitment to making Bempikibart a viable alternative for those in need.

About Q32 Bio

Q32 Bio is committed to innovative solutions targeting the adaptive immune system to restore balance and functionality within immune responses. With approximately 700,000 individuals in the United States affected by alopecia areata, the impact of this condition is far-reaching and can significantly alter the quality of life for patients. Bempikibart presents a unique approach by targeting key pathways implicated in several autoimmune disorders. As they navigate through clinical trials, Q32 Bio remains focused on advancing this and other therapeutic options in pursuit of meaningful patient outcomes.

For further information about Q32 Bio and its endeavors, please visit www.Q32Bio.com.