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4D Molecular Therapeutics Announces FDA Clearance of IND Application for 4D-150, a Dual-Transgene Intravitreal Gene Therapy for Patients with wet AMD
Initiation of 4D-150 Phase 1/2 clinical trial sites expected before year-end EMERYVILLE, Calif., Oct. 06, 2021 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics
About this update from 4d Molecular Therapeutics, Inc.
[{"type":"text","content":"Initiation of 4D-150 Phase 1/2 clinical trial sites expected before year-end\nEMERYVILLE, Calif., Oct. 06, 2021 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT), a clinical-stage gene therapy company harnessing the power of directed evolution for targeted gene therapies, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for 4D-150 for wet age-related macular degeneration (wet AMD). The active IND enables the initiation of 4D-150 Phase 1/2 clinical trial sites, which is expected before year-end. “4D-150 is a dual-transgene intravitreal gene therapy encompassing the R100 capsid which was invented through Therapeutic Vector Evolution with the goal of robust and safe delivery to all regions and major cell types within the retina at relatively low doses,” said David Kirn, M.D., Co-Founder and Chief Executive Officer of 4DMT. “We believe that 4D-150’s design, which targets four distinct angiogenic factors with dual transgenes, has the potential for broad, robust and durable efficacy after a single low dose intravitreal administration in patients with wet AMD. 4D-150 has the potential to be administered at significantly lower doses compared to other intravitreal AAV gene therapy approaches, and 4D-150 clinical development builds on the favorable tolerability profile to date with the same R100 capsid utilized in our 4D-125 X-linked retinitis pigmentosa (XLRP) program at significantly higher doses. While 4D-125 has been well-tolerated at 1E12 vg/eye, we believe 4D-150 has the potential for clinical activity at substantially lower doses.” “4D-150 represents numerous firsts in the AAV gene therapy space and underscores 4DMT’s commitment to innovation,” said Peter Francis, M.D., Ph.D., Chief Scientific Officer. “4D-150 is the first R100-based product candidate to enter clinical development in a large market disease. In addition, it is not only the first clinical-stage dual-transgene AAV gene therapy utilizing an evolved vector, but also the first vectorized RNAi AAV gene therapy product candidate utilizing an evolved vector to enter clinical development.” The Phase 1/2 clinical trial is a dose-escalation and randomized, controlled, masked expansion trial of intravitreal 4D-150 and is expected to enroll approximately 60 adults with wet AMD. In the dose-escalation...