4D Molecular Therapeutics announces positive initial interim 24-week landmark data from population extension cohort of PRISM phase 2 clinical trial of 4D-150

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4D Molecular Therapeutics (4DMT) has announced positive initial interim 24-week landmark data from the Population Extension cohort of its PRISM phase 2 clinical trial of 4D-150 in wet age-related macular degeneration (AMD).

Raj K. Maturi, MD, presented the data in an oral presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting held in Stockholm, Sweden.

David Kirn, MD, co-founder and CEO of 4DMT commented on the results in a press release from the company.¹

“The growing safety and efficacy database for 4D-150 continues to validate the product candidate’s potential as a pipeline-in-a-product, with multiple potential multi-billion ophthalmology market opportunities including wet AMD, diabetic macular edema (DME) and diabetic retinopathy (DR). We anticipate data readouts from the SPECTRA study in DME in Q4 this year, which we believe will have potential readthrough to DR.”

The Population Extension cohort of 4D-150 evaluated the product in wet AMD patients with broad disease activity (no minimum or maximum central subfield thickness) and prior anti-VEGF treatment (1-6 anti-VEGF injections in the prior 12 months). It enrolled 45 patients at 2 dose level arms; 30 at 3E10 vg/eye and 15 at 1E10 vg/eye, the latter being a low-dose control.

Results from the company showed that 4D-150 was safe and well tolerated. The 3E10 vg/eye dose showed no anterior chamber inflammation and no significant vitreous inflammation (trace vitreal cells noted in 1 patient). The company also noted that there were no serious adverse events reported, and no hypotony, retinal vasculitis, choroidal effusions, retinal artery occlusions.

Furthermore, results from the 3E10 vg/eye treatment in robust anti-VEGF treatment reduction showed an 89% reduction in mean annualized injection rate, with 93% receiving 0 or 1 injection.

Best corrected visual acuity (BCVA) in the 3E10 vg/eye arm patients showed a +4.2 Early Treatment Diabetic Retinopathy Study (ETDRS) letter improvement from baseline overall, and a +4.7 letter improvement observed for injection-free patients (improvement independent of number of prior anti-VEGF doses).

Follow-up data from the phase 1 PRISM trial showed that all 3 patients treated with 3E10 vg/eye previously reported as injection-free beyond 52 weeks remain injection-free, BCVA remains unchanged from baseline, and central subfield thickness remains stable with no fluctuations.

Looking ahead, 4DMT is planning phase 3 clinical trial ongoing with FDA and EMA under RMAT and PRIME designations. Final phase 3 clinical trial design details are expected in September 2024 with the first initiation expected in Q1 of 2025.

References:

1. 4DMT Announces Positive Phase 2 PRISM Results for Intravitreal 4D-150 in a Broad Wet AMD Population Affirming Favorable Safety Profile and Robust Clinical Activity. Press release. Released July 17, 2024. Accessed July 16, 2024.