Q32 Bio Inc. announced a corporate restructuring on February 10, 2025, to strategically focus on advancing its bempikibart clinical development program for the treatment of patients with alopecia areata (AA). As part of this restructuring, the company is discontinuing the Phase 2 renal basket clinical trial of ADX-097 and is evaluating strategic options for its broader tissue-targeted complement inhibitor platform. This decision aims to conserve resources and maximize the potential of bempikibart.
The restructuring includes other cost-saving measures, such as a reduction in personnel and related expenses. These actions are expected to extend the company's cash runway into the second half of 2026. Q32 Bio expressed conviction in bempikibart's differentiated potential in AA, citing continued data emergence from SIGNAL-AA Part A, robust pharmacologic data, and a well-tolerated safety profile.
The company plans to initiate an open-label extension (OLE) for eligible SIGNAL-AA Part A patients and begin dosing in SIGNAL-AA Part B in the first half of 2025. Topline data from SIGNAL-AA Part B is anticipated in the first half of 2026. The discontinuation of ADX-097's renal basket trial represents a significant pivot in the company's pipeline strategy.
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