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4D Molecular announces updates on clinical pipeline
The Fly

4D Molecular announces updates on clinical pipeline

4D Molecular Therapeutics announced product pipeline portfolio updates and preclinical product candidate additions for its large market ophthalmology and pulmonology programs, as well as clinical data and program updates for its 4D-310 Fabry disease program. Ophthalmology Product Candidate Portfolio: 4D-150 for the Intravitreal Treatment of Patients with Wet Age-Related Macular Degeneration and Patients with Diabetic Macular Edema, DME. Filed IND Application for Phase 2 SPECTRA Clinical Trial with Intravitreal 4D-150 in Patients with DME: 4DMT filed an Investigational New Drug Application for 4D-150 in patients with DME in December 2022, following pre-IND correspondence and alignment with the FDA. expects to initiate enrollment in the third quarter of 2023. Initiated Randomized Phase 2 of PRISM Clinical Trial of Intravitreal 4D-150 in Patients with Wet AMD: This Phase 2 stage of the trial was initiated in January 2023. Expanded Portfolio with Preclinical Product Candidate 4D-175 for Geographic Atrophy: Preclinical development was initiated for a new product candidate designed for single dose intravitreal treatment of patients with GA; the product candidate will utilize 4DMT’s proprietary R100 intravitreal vector currently used in the wet AMD and DME programs, and a transgene payload that addresses a complement pathway target. Program Updates on Rare Disease Product Candidates 4D-125 for XLRP and 4D-110 for Choroideremia: Enrollment on the Phase 1/2 clinical trials for 4D-125 and 4D-110 was completed in the fourth quarter of 2022: 14 patients have been treated with 4D-125, and 13 with 4D-110. Anticipates providing program and clinical data updates in 2024. Pulmonology Product Portfolio: 4D-710 for the Aerosol Treatment of Patients with Cystic Fibrosis Lung Disease: Treated First Patient in High Dose Cohort on Phase 1/2 Clinical Trial with Aerosol Delivered 4D-710 in Patients with Cystic Fibrosis Lung Disease that is Not Amenable to Treatment with CFTR Modulator Therapy.

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