4D Molecular Therapeutics Announces FDA Clearance of IND Application for 4D-150 Genetic Medicine
Friday, February 03, 2023
4D Molecular Therapeutics announced FDA clearance of the Investigational New Drug Application (IND) for 4D-150, an R100 vector-based intravitreal genetic medicine, for the treatment of patients with Diabetic Macular Oedema (DME).
4D-150 Phase 2 SPECTRA clinical trial for diabetic macular oedema enrolment is expected to initiate in Q3 2023.
Initial Phase 1 PRISM clinical trial with 4D-150 for wet age-related macular degeneration validates R100 intravitreal vector potential for other large market eye diseases including geographic atrophy.
4D-150 comprises of targeted and evolved intravitreal vector, R100, and a payload that expresses both aflibercept and a VEGF-C RNAi. R100 invented at 4DMT through a proprietary Therapeutic Vector Evolution platform. This dual transgene payload inhibits 4 angiogenic factors: VEGF A, B, C and PlGF. 4D-150 is designed for a single low dose intravitreal delivery.
The study design consists of a Dose Confirmation stage followed by a masked Dose Expansion stage, in which patients will be randomised 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). The doses to be evaluated in DME are anticipated to be between 6E9 to 3E10 vg/eye. The IND clearance enables the initiation of SPECTRA clinical study sites, and 4DMT expects to begin enrolment in the third quarter of 2023.
