The company anticipates providing program and clinical data updates in 2024. The company will continue to follow these patients for 24 months to assess the magnitude and durability of key imaging endpoint changes in evaluable patients. The safety and tolerability profiles for both product candidates remain unchanged from prior data releases. 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. The company anticipates that development and manufacturing activities will benefit from prior clinical experience and GMP manufacturing of three other R100-based ophthalmology product candidates that have been dosed in ophthalmology patients with wet AMD, X-Linked Retinitis Pigmentosa (XLRP) and choroideremia. 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 (undisclosed). There are no disease modifying therapies approved for GA to date. It is estimated that there are over one million individuals with GA in the United States according to published data. This Phase 2 stage of the trial was initiated in January 2023.Įxpanded Portfolio with Preclinical Product Candidate 4D-175 for Geographic Atrophy (GA): Geographic atrophy is a highly prevalent disease with significant unmet medical need. Patients will be randomized in masked fashion to receive a single intravitreal injection at one of two dose levels of 4D-150 (3E10 and 1E10 vg/eye) or aflibercept in a 2:2:1 ratio (n=50 patients). Initiated Randomized Phase 2 of PRISM Clinical Trial of Intravitreal 4D-150 in Patients with Wet AMD: The Phase 2 stage of the Phase 1/2 PRISM clinical trial of 4D-150 in patients with wet AMD consists of three treatment groups. The company expects to initiate enrollment in the third quarter of 2023. The doses to be evaluated in DME are expected to be similar to those used in the 4D-150 wet AMD clinical trial. The Phase 2 SPECTRA clinical trial design consists of a Dose Confirmation stage followed by a masked Dose Expansion stage in which patients will be randomized to receive a single intravitreal injection at one of two dose levels of 4D-150 or aflibercept in a 1:1:1 ratio (n=54 patients). Filed IND Application for Phase 2 SPECTRA Clinical Trial with Intravitreal 4D-150 in Patients with DME: 4DMT filed an Investigational New Drug (IND) Application for 4D-150 in patients with DME in December 2022, following pre-IND correspondence and alignment with the FDA. Ophthalmology Product Candidate Portfolio: 4D-150 for the Intravitreal Treatment of Patients with Wet Age-Related Macular Degeneration (wet AMD) and Patients with Diabetic Macular Edema (DME). 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.
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