Q32 Bio recently announced mixed results from its Phase 2 clinical trials of bempikibart (ADX-914) for atopic dermatitis (AD) and alopecia areata (AA). The SIGNAL-AD trial, targeting moderate-to-severe AD, did not achieve its primary endpoint in Part B, despite promising findings in Part A. Conversely, the SIGNAL-AA trial for severe AA showed encouraging clinical activity, with patients treated with bempikibart experiencing a mean reduction in SALT score of 16% at week 24, compared to a 2% reduction in the placebo group.
Following these announcements, Q32 Bio’s stock experienced a significant decline, dropping 67%. Analysts described the trial outcomes as “messy,” contributing to the sharp decrease in stock value.
In response to the SIGNAL-AA results, Q32 Bio plans to expand the trial by enrolling approximately 20 additional patients to further evaln AA, including a loading regimen. The company will also defer enrollment into the planned Phase 2 clinical trial of ADX-097 in ANCA-Associated Vasculitis to focus on the ongoing bempikibart AA and ADX-097 renal basket Phase 2 clinical trials.
Bempikibart is a fully human anti-IL-7Rα antibody designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling, both of which contribute to inflammation in various autoimmune disorders. Q32 Bio regained worldwide rights to bempikibart from Amgen in November 2023, bolstering its autoimmune product portfolio.
The company remains committed to advancing bempikibart through its clinical programs, aiming to address unmet needs in autoimmune and inflammatory diseases.
