Business
Q32 Bio Announces Strategic Restructuring to Focus on Advancement of Bempikibart in Patients with Alopecia Areata
-- Based on continued emergence of bempikibart data from SIGNAL-AA Part A, including strong re-consent rates and patient demand for continued dosing, Company
About this update from Q32 Bio Inc.
[{"type":"text","content":"-- Based on continued emergence of bempikibart data from SIGNAL-AA Part A, including strong re-consent rates and patient demand for continued dosing, Company initiating open-label extension in 1H'25; SIGNAL-AA Part B remains on track for initiation of dosing in 1H'25, with topline data expected in 1H'26 --\n-- Company to discontinue renal basket trial for ADX-097 to conserve resources and evaluate strategic options for its tissue-targeted complement inhibitor platform --\n-- Cash runway expected to extend to 2H'26 --\nWALTHAM, Mass., Feb. 10, 2025 /PRNewswire/ -- Q32 Bio Inc. (Nasdaq: QTTB) (\"Q32 Bio\"), a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis, today announced a corporate restructuring to focus on the advancement of its bempikibart clinical development program for the treatment of patients with alopecia areata (AA). As part of the restructuring, the Company is discontinuing the Phase 2 renal basket clinical trial of ADX-097 and is evaluating strategic options for its tissue-targeted complement inhibitor platform, inclusive of ADX-097 and early-stage assets. In combination with other cost-saving measures including a reduction in personnel and related expenses, the strategic restructuring is expected to extend cash runway to the second half of 2026.\n\n \n \n \n \n \n \n\n \n\"We have conviction that bempikibart is differentiated from existing AA therapies and has the potential to transform the treatment paradigm for this disease. This is based on the continued emergence of bempikibart data in alopecia areata patients with longer-term follow-up from Part A of the SIGNAL-AA Phase 2a clinical trial, the robust pharmacologic data, and a well-tolerated safety profile,\" said Jodie Morrison, Chief Executive Officer of Q32 Bio. \"Further, based on the clinical characteristics of bempikibart, we continue to believe there is potential utility across additional autoimmune conditions. Our immediate next steps will be to extend dosing of eligible patients from SIGNAL-AA Part A in an open-label extension arm and to initiate dosing of patients in the SIGNAL-AA Part B clinical trial in the first half of 2025, with Part B topline data expected in the first half of 2026.\"\nMorrison added, \"ADX-097, our Phase 2 complement inhibitor, is a clinical asset with strong potentia...