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4D Molecular Therapeutics Presents Interim Results from the Ongoing 4D-125 Phase 1/2 Clinical Trial in Patients with Advanced X-linked Retinitis Pigmentosa at the ASRS Annual Meeting
4D-125 was well tolerated in all patients treated to-date (n=8), with no dose-limiting toxicities, no serious adverse events and no chronic
About this update from 4d Molecular Therapeutics, Inc.
[{"type":"text","content":"4D-125 was well tolerated in all patients treated to-date (n=8), with no dose-limiting toxicities, no serious adverse events and no chronic inflammationClinical activity observed through anatomical measurements of reduced photoreceptor loss in treated vs untreated control eyes on ellipsoid zone area endpointsClinical activity observed through functional improvements in treated vs untreated control eyes on two microperimetry endpoints: (1) mean retinal sensitivity and (2) number of loci with >7 dB improvement4DMT plans to continue enrollment at the 1E12 vg/eye in the dose expansion cohort, including in less advanced patients4DMT to host conference call and webcast on Monday, October 11, 2021 at 8:00 a.m EDT EMERYVILLE, Calif., Oct. 10, 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 interim safety and clinical activity data from the Phase 1/2 clinical trial of intravitreal 4D-125 in patients with advanced X-linked retinitis pigmentosa (XLRP). The interim data were presented today in a late-breaking presentation at the American Society of Retina Specialists (ASRS) 39th Annual Meeting. “These are the first clinical data reported with a product invented from our Therapeutic Vector Evolution platform at 4DMT, and these interim data demonstrate clinical proof-of-concept for safety, tolerability and clinical activity,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “These data support our belief that 4D-125 is well tolerated, and has the potential to both slow the progressive loss of photoreceptors in patients with XLRP after a single intravitreal injection and to improve visual function. We believe these results validate the potential of our platform, and of the R100 vector, which is also deployed in 4DMT targeted product candidates designed to treat a variety of large market diseases. Consistent with our prior guidance, we expect our first R100-based large-market product candidate, 4D-150 for wet AMD, to enter clinical development before year-end.” “Given the encouraging data we have seen with our intravitreal gene therapy, we plan to continue enrolling patients at the top dose level of 1E12 vg/eye in the dose expansion cohort, including treatment of patients with less adva...