Q32 Bio Reports Third Quarter 2024 Financial Results and Provides Corporate Update

In This Article:

-- Bempikibart Phase 2 topline results in atopic dermatitis (AD) and alopecia areata (AA) remain on-track for Q4'24, with topline data from both trials expected in December --

-- Enrollment ongoing in ADX-097 Phase 2 basket trial for complement mediated renal diseases, with topline data expected in 2H'25 and initial open-label data in 1H'25 --

-- Cash and cash equivalents of $89.1 million as of September 30, 2024 expected to provide financial runway through four Phase 2 clinical milestones and into mid-2026 --

WALTHAM, Mass., Nov. 7, 2024 /PRNewswire/ -- Q32 Bio Inc. (Nasdaq: QTTB) ("Q32 Bio"), a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis, today reported financial results for the quarter ended September 30, 2024, and provided recent corporate updates.

"In the third quarter of 2024, we continued to make important strides advancing our two Phase 2 clinical trials evaluating bempikibart in AD and AA, with both trials remaining on-time, even with the over-enrollment in AD, and we remain focused on releasing topline data for both clinical trials this quarter," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "We believe bempikibart has the potential to bring a differentiated, disease-modifying treatment to patients with AD and AA and look forward to sharing our results. In parallel, we continue to advance our Phase 2 basket trial of ADX-097 in complement mediated renal diseases with initial open-label Phase 2 data expected in the first half of 2025 after we release bempikibart data this quarter, and we continue to expect topline results in the second half of 2025. Additionally, we are continuing our preparations to commence the ADX-097 Phase 2 trial in ANCA-Associated Vasculitis (AAV) in the first half of 2025."

Third Quarter 2024 and Recent Business Highlights

  • Bempikibart SIGNAL-AD Phase 2 clinical trial in AD remains on-track, with topline results expected to be released in December 2024. Bempikibart is a fully human anti-IL-7Rα antibody that is designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling, both of which contribute to inflammation and injury in a diversity of autoimmune disorders. SIGNAL-AD is a two-part Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating bempikibart in adult patients with persistent, moderate-to-severe AD. Part A was conducted to evaluate safety, PK, and to enable dose selection for Part B of the clinical trial. Part A was completed, but data remains blinded. Part B is being conducted to evaluate the efficacy and safety of bempikibart as compared with placebo. In Part B, patients were enrolled 1:1 in the bempikibart 200 mg every-other-week (Q2W) subcutaneous (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. A total of 121 patients were enrolled, including 15 patients in Part A. Total enrollment exceeded the initial target of approximately 100 patients due to Part B patient enrollment demand.

  • Bempikibart SIGNAL-AA Phase 2 clinical trial in AA remains on track, with topline results expected in December 2024. SIGNAL-AA is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating bempikibart in patients with severe AA treated over 24 weeks. Patients were randomized 3:1 in the bempikibart 200 mg Q2W 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 is underway in the Phase 2 basket trial of ADX-097 for complement mediated renal diseases. ADX-097 is designed to be a tissue-targeted inhibitor of complement activation while minimizing systemic complement blockade and is being studied for the treatment of patients with renal diseases associated with increased complement activation. The Phase 2 open label clinical trial is evaluating the safety, pharmacodynamics, pharmacokinetics, and clinical activity of ADX-097 administered subcutaneously in participants with IgA Nephropathy (IgAN), Lupus Nephritis (LN), or C3 Glomerulopathy (C3G). Initial open-label data is expected in the first half of 2025, and topline results expected in the second half of 2025. Q32 Bio also plans to evaluate ADX-097 in a Phase 2 clinical trial in ANCA-Associated Vasculitis (AAV), which is expected to commence in the first half of 2025 with topline results also expected in the second half of 2025.

  • Positive Phase 1 clinical trial results from tissue-targeted complement inhibitor ADX-097 were presented at ASN Kidney Week 2024. The poster presentation at ASN highlighted data from the first-in-human, Phase 1 ascending dose clinical trial of ADX-097 in healthy volunteers. ADX-097 demonstrated a favorable safety profile and desired PK/PD properties, supporting a Phase 2 dose that is predicted to provide tissue inhibition of complement in glomerular diseases while sparing systemic complement activity.

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