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Homology Medicines Announces Plan to Evaluate Strategic Options for the Company and its Genetic Medicines Programs, including HMI-103 Gene Editing Candidate for PKU
Announced Today Encouraging Initial Clinical Data from First Dose Level of pheEDIT Trial Evaluating HMI-103 BEDFORD, Mass., July 27, 2023 (GLOBE NEWSWIRE) --
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[{"type":"text","content":"Announced Today Encouraging Initial Clinical Data from First Dose Level of pheEDIT Trial Evaluating HMI-103 BEDFORD, Mass., July 27, 2023 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today that it has completed a review of its business, and the Board of Directors has approved a plan to evaluate strategic alternatives to maximize shareholder value. Earlier today, Homology reported encouraging initial data from the first dose level in the Phase 1, dose-escalation trial evaluating gene editing candidate HMI-103 in adults with classical phenylketonuria (PKU), which showed it was generally well-tolerated in all three participants and resulted in a meaningful reduction in plasma phenylalanine (Phe) in two participants as of the data cut-off date of July 26, 2023. Despite these encouraging data, based on the current financing environment and Homology’s anticipated clinical development timelines, Homology will not be further developing its programs and will be instituting a related reduction in force while it explores options for the Company and its assets, including HMI-103. Homology has retained TD Cowen as its strategic financial advisor. “We are pleased with the initial data from the first dose level in our PKU gene editing trial, which support dose-escalation; however, given today’s tough financing conditions and the expected clinical development timeline for HMI-103, we believe the best path forward for our shareholders is to evaluate all strategic options for the Company and our pipeline,” said Albert Seymour, Ph.D., President and Chief Executive Officer. “Unfortunately, this decision impacts our dedicated employees, and I would like to extend my sincere gratitude to our affected colleagues who have been instrumental in building Homology’s platform and programs, and we are committed to supporting them as best as we can during this transition.” Homology has gene editing and gene therapy clinical-stage programs in PKU and Hunter syndrome (MPS II), a preclinical pipeline that includes a gene therapy candidate for metachromatic leukodystrophy and a GTx-mAb (vectorized antibody) candidate for paroxysmal nocturnal hemoglobinuria, as well as intellectual property on its family of 15 adeno-associated viruses (AAVHSCs). Additionally, the Company has a 20 percent stake in Oxford Biomed...