4D Molecular announces interim data on 4D-150 SPECTRA clincial trial

4D Molecular (FDMT) Therapeutics announced topline interim data from Part 1 of the SPECTRA clinical trial evaluating 4D-150 in diabetic macular edema and alignment with the U.S. Food and Drug Administration on registrational pathway for 4D-150 in DME. Clinical Trial Design & Interim Data from 4D-150 SPECTRA Part 1 Clinical Trial: Objectives: Evaluate safety and tolerability and identify dose level for further evaluation; Utilized stringent supplemental aflibercept criteria and enrolled patients with high central subfield thickness to maximize patient safety and assess initial clinical activity. Study Population: 22 patients enrolled across 3 dose levels: 3E10 vg/eye, 1E10 vg/eye, 5E9 vg/eye; 1 patient in 1E10 vg/eye arm terminated the study due to death unrelated to 4D-150, prior to completion of a post-baseline assessment. Safety: 4D-150 was well tolerated with no intraocular inflammation at any timepoint; All patients completed the 16-week topical corticosteroid taper on schedule and remained completely off steroids; No hypotony, endophthalmitis, vasculitis, choroidal effusions or retinal artery occlusions. Efficacy Results Through 32 Weeks: 3E10 vg/eye arm: Sustained gain of best corrected visual acuity of +8.4 letters; Sustained reduction of CST, as measured by optical coherence tomography, of -194 microm. Supplemental injections: Post-aflibercept loading doses, 3E10 vg/eye achieved substantially fewer supplemental injections compared to 1E10 vg/eye and projected on-label aflibercept 2mg Q8W: Mean injections per patient: 3E10 vg/eye: 0.6, 1E10 vg/eye: 1.4, projected on-label aflibercept 2mg Q8W: 4.0; 3E10 vg/eye demonstrated a reduction of 61% vs. 1E10 vg/eye; 3E10 vg/eye demonstrated a reduction of 86% vs. projected on-label aflibercept 2mg Q8W. 0-1 injections: 8 of 9 overall vs. 5 of 10; Injection-free: 5 of 9 overall vs. 2 of 10 overall; 5 of 8 in patients treated per protocol. Results to be presented in a corporate webcast on February 10, 2025. 52-week interim data update expected at a scientific conference in mid-2025. 4D-150 DME Phase 3 Regulatory Update & Next Steps: 3E10 vg/eye has been selected as the Phase 3 dose; Based on data generated to date for 4D-150 in both the SPECTRA and PRISM clinical trials, FDA is aligned that a single Phase 3 clinical trial, combined with data from the two planned Phase 3 clinical trials in the 4FRONT wet AMD program, would be acceptable as the basis of a BLA submission for 4D-150 in DME. Per FDA feedback, the Company may proceed to Phase 3 and is aligned with key design elements of a Phase 3 clinical trial with approximately 300-400 patients total with a primary endpoint of BCVA noninferiority vs. on-label aflibercept 2mg and revised supplemental injection criteria . Next steps for DME development to be presented in a corporate webcast on February 10, 2025.