4DMT Presents Positive Interim Data from Intravitreal 4D-150 Phase 1/2 PRISM Clinical Trial in Patients with Wet AMD at ARVO 2023

• Intravitreal 4D-150 was well-tolerated with no inflammation in 14 of 15 patients and only trace mixed cells at a single timepoint in one patient; no dose-limiting toxicities, treatment-related serious adverse events (SAE) or hypotony reported across all three dose cohorts with follow-up of 24 – 64 weeks
• Dose response demonstrated in favor of high dose 3E10 vg/eye, including superior reduction in supplemental anti-VEGF injections and mean central subfield thickness (CST) reduction
• 80% of patients in the 3E10 vg/eye high dose cohort did not require supplemental anti-VEGF injections through 36 weeks following a single intravitreal dose of 4D-150
• Clinically-meaningful improvement in mean CST of -92 µm at 36 weeks, and stable best corrected visual acuity (BCVA), following a single 3E10 vg/eye intravitreal dose of 4D-150
• Phase 2 Dose Expansion stage of PRISM trial (n=50 patients) more than 50% enrolled; enrollment completion expected Q3 this year
• Company to host live webcast today at 8:00 a.m. ET with retinal expert Arshad Khanani, M.D., M.A., FASRS

Excerpt from the Press Release:

EMERYVILLE, Calif., April 27, 2023 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced positive interim clinical data from the Phase 1 Dose Exploration stage (three doses, n=15) of the 4D-150 Phase 1/2 PRISM clinical trial for wet age-related macular degeneration (wet AMD). 4D-150, a novel genetic medicine that utilizes 4DMT’s evolved and customized R100 vector for intravitreal delivery to the retina, was well- tolerated at all doses. All doses demonstrated clinical activity, including a reduction in anti-VEGF injection burden, stable or improved retinal edema and thickness, and stable visual acuity. A dose response was demonstrated in favor of the high dose 3E10 vg/eye. Interim data from the study will be presented today in an oral presentation titled, “Interim results for the Phase 1/2 PRISM Trial evaluating 4D-150, a dual-transgene intravitreal genetic medicine in individuals with neovascular (wet) age-related macular degeneration,” at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in New Orleans, LA at 11:30 a.m. ET.

“4D-150 is the first retinal genetic medicine that is designed to inhibit all four VEGF-related molecules that drive disease in wet AMD,” said Robert Kim, M.D., Chief Medical Officer. “We are impressed by the clinical activity reported today, especially in the high dose cohort where 80% of patients did not require anti-VEGF injections through 36 weeks. We continue to execute relentlessly on enrolling the Phase 2 Dose Expansion stage of the PRISM trial in an effort to advance this potentially transformative therapy into late-stage development as soon as possible.”

Arshad M. Khanani, M.D., M.A., FASRS, Managing Partner and Director of Clinical Research at Sierra Eye Associates, Clinical Associate Professor at University of Nevada, Reno, and a Principal Investigator in the 4D-150 PRISM clinical trial, added, “I continue to be encouraged by the tolerability and clinical activity of a single intravitreal injection of 4D-150 in high-need patients with wet AMD.

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