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4DMT Completes Enrollment of Phase 2 PRISM Clinical Trial for Intravitreal 4D-150 in Patients with Wet AMD and Reports Interim Safety and Tolerability Data
Completed target enrollment of 50 patients in the randomized Phase 2 Dose Expansion stage of the PRISM clinical trial over approximately two quarters, nearly
About this update from 4d Molecular Therapeutics, Inc.
[{"type":"text","content":"Completed target enrollment of 50 patients in the randomized Phase 2 Dose Expansion stage of the PRISM clinical trial over approximately two quarters, nearly two quarters ahead of initial projections No reported treatment-emergent Grade ≥1 inflammatory cells or required deviations from protocol-specified topical corticosteroid taper, and no hypotony or treatment-related serious adverse events with maximum follow-up through 20 weeks (best available data as of July 3, 2023) Initial interim Phase 2 efficacy data expected to be presented at a medical conference in H1 2024 Expect to provide update regarding Phase 3 pivotal trial plans in Q1 2024 after discussion with FDA in Q4 2023 EMERYVILLE, Calif., July 17, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced that it has completed enrollment of the Phase 2 Dose Expansion stage of the PRISM clinical trial for patients with wet age-related macular degeneration (wet AMD) over approximately two quarters, and that no significant 4D-150 safety events or inflammation have been reported to date. “The rapid enrollment of the Phase 2 Dose Expansion stage of the PRISM trial is indicative of the high demand by wet AMD patients and physicians for a new safe and effective therapy delivered by routine outpatient intravitreal injection with the potential to significantly reduce the need for frequent anti-VEGF injections,” said Robert Kim, M.D., Chief Medical Officer of 4DMT. “We thank the PRISM investigators and patients for their enthusiasm for this important study as we rapidly advance 4D-150 towards the next stage of development.” The Dose Expansion stage of the PRISM trial is a multicenter, randomized study designed to evaluate the safety and efficacy of 4D-150 at two different dose levels in wet AMD patients with high anti-VEGF need (annualized mean anti-VEGF injection frequency in preceding 12 months was approximately 10). The targeted enrollment of the trial was 50 wet AMD patients randomized 2:2:1 to 3E10 vg/eye or 1E10 vg/eye of 4D-150 or aflibercept. The Best-Corrected Visual Acuity (BCVA) inclusion criteria at baseline for this stage was 34-83 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared to 25-78 f...