Q32 Bio Provides Bempikibart Program Update, Including Next Steps for Advancing Alopecia Areata Development Program

In This Article:

-- SIGNAL-AA demonstrated encouraging clinical activity of bempikibart in patients with alopecia areata (AA), including improvement from baseline on SALT score and meaningful achievement of SALT-20 response --

-- SIGNAL-AD Phase 2a clinical trial in atopic dermatitis demonstrated promising findings in Part A but did not meet primary endpoint in Part B --

-- Across both trials, bempikibart was observed to be safe and well tolerated; demonstrated potent IL-7 and TSLP inhibition via changes in both Th2 biomarkers and T-cells, and desired target engagement --

-- Based on these results, Company plans to advance bempikibart in patients with AA --

WALTHAM, Mass., Dec. 10, 2024 /PRNewswire/ -- Q32 Bio Inc. (Nasdaq: QTTB) ("Q32 Bio"), a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis, today announced topline results from the SIGNAL-AA Phase 2a signal finding clinical trial evaluating bempikibart (ADX-914), which identified encouraging clinical activity in patients with alopecia areata (AA). The Company plans to expand the SIGNAL-AA Phase 2a clinical trial and enroll additional patients evaluating bempikibart in AA.

"We are pleased with the emerging signals observed in the SIGNAL-AA Phase 2a clinical trial and based upon these, the positive biomarker data and well tolerated safety profile observed across both trials, we plan to enroll additional patients into the SIGNAL-AA clinical trial to further explore the clinical effects of bempikibart in this patient population. We believe bempikibart has the potential to be an important new treatment option in a disease needing new and safer alternatives to currently approved agents," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "We are disappointed that the SIGNAL-AD trial did not achieve its primary endpoint. Based upon the findings, including the high placebo rate, we plan to conduct a review to better understand the results."

"Results from our analysis of SIGNAL-AA showed clinically meaningful activity and a safety profile that we believe is differentiated from the currently approved therapies for AA. We are encouraged by our findings from this clinical trial, and we look forward to advancing bempikibart as a potential treatment for AA," said Jason Campagna, M.D., Ph.D., Chief Medical Officer of Q32 Bio. "On behalf of Q32 Bio, I want to express my gratitude to the patients, their caregivers, and clinical trial sites that participated across both our bempikibart Phase 2a trials."


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