Q32 Bio Inc. provided corporate update. Enrollment was completed in the ongoing bempikibart Phase 2 clinical trial in AA, with topline results expected in the fourth quarter of 2024. Bempikibart is a fully human anti-IL-7R antibody designed to re-regulate adaptive immune function by blocking signaling mediated by both IL-7 and TSLP.

The Phase 2 clinical trial is ongoing in approximately 40 patients with severe AA treated over 24 weeks. Patients were randomized 3:1 in the bempikibart 200 mg every-other-week (Q2W) subcutaneous (SC) flat-dose and placebo arms. The primary endpoint is the mean percent change from baseline on the Severity of Alopecia Tool (SALT) score at week 24. Patients will be followed for an additional 12 weeks following completion of treatment.

Enrollment remains on-track in the bempikibart Phase 2 clinical trial in AD, with topline results expected in the fourth quarter of 2024. The Phase 2 clinical trial in AD is approximately 100 patients and consists of two parts. Part A was conducted to evaluate safety, PK, and to enable dose selection for the ongoing Part B of the clinical trial.

Part A was completed, but data remains blinded. In Part B, patients are being enrolled 1:1 in the bempikibart 200 mg Q2W SC flat-dose and placebo arms for 12 weeks of treatment. The primary endpoint is the mean percent change from baseline to week 14 in the Eczema Area and Severity Index (EASI) score.

Patients will be followed for an additional 12 weeks following completion of treatment. ADX-097 continues to advance, with topline results from two Phase 2 clinical trials expected in the second half of 2025. ADX-097 is based on company's novel complement inhibitor platform and is designed to enable tissue-targeted regulation of the complement system without long-term systemic blockade, a key differentiator from current complement therapeutics.

A Phase 2 renal basket program is planned to commence in the first half of 2024 and a Phase 2 clinical trial in ANCA-Associated Vasculitis (AAV) is planned to commence in the first half of 2025. Topline results from both trials are expected in the second half of 2025, with initial open-label renal basket data expected by year-end 2024.