Q32 Bio Inc. announced topline results from its SIGNAL-AA Phase 2a clinical trial for alopecia areata (AA) and provided an update on the SIGNAL-AD trial for atopic dermatitis (AD) on December 10, 2024. The SIGNAL-AA trial demonstrated encouraging clinical activity of bempikibart, including improvement from baseline on SALT score and meaningful achievement of SALT-20 response. Based on these findings, the company plans to expand the SIGNAL-AA Phase 2a trial and enroll approximately 20 additional patients.
In contrast, the SIGNAL-AD Phase 2a clinical trial in atopic dermatitis did not meet its primary endpoint in Part B. Patients treated with bempikibart showed a 74% improvement in average EASI from baseline, compared to 76% for the placebo group, which was not statistically significant. The company plans to conduct a review to understand these results, including a high placebo rate.
Across both trials, bempikibart was observed to be safe and well-tolerated, with no serious adverse events or Grade 3 or higher adverse events related to treatment. Biomarker data showed potent IL-7 and TSLP inhibition, with substantial reductions in Th2 biomarkers and expected changes in T-cells. Q32 Bio will defer enrollment into the planned Phase 2 trial of ADX-097 in ANCA-Associated Vasculitis to focus on bempikibart AA and the ADX-097 renal basket trials.
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