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4D Molecular Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of 4D-150, a Dual-Transgene Intravitreal Gene Therapy for Patients with wet AMD

Excerpt from the Press Release:

EMERYVILLE, Calif., Jan. 06, 2022 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics, Inc. (4DMT) (Nasdaq: FDMT), a clinical-stage gene therapy company harnessing the power of directed evolution for targeted gene therapies, announced that the first patient has been dosed in the Phase 1/2 clinical trial of 4D-150 for neovascular age-related macular degeneration (wet AMD).

“The dosing of the first patient in the 4D-150 Phase 1/2 clinical trial in wet AMD marks an important milestone for our company and for the patients we aim to serve. 4D-150 is a dual-transgene intravitreal gene therapy incorporating the R100 capsid which we invented through our proprietary Therapeutic Vector Evolution platform,” said David Kirn, M.D., Co-Founder and Chief Executive Officer of 4DMT.

“We believe that 4D-150’s design, which targets four distinct angiogenic factors with dual transgenes, has the potential for broad, robust and durable efficacy after a single low dose intravitreal administration in patients with wet AMD,” said Robert Kim, M.D., Senior Vice President and Ophthalmology Therapeutic Area Head of 4DMT.

“While there have been significant advances in the treatment of wet AMD, the treatment burden remains significant, and as a result, many patients experience suboptimal vision outcomes,” said Arshad Khanani, M.D., M.A., Managing Partner, Director of Clinical Research at Sierra Eye Associates and a principal investigator on the 4D-150 Phase 1/2 clinical trial. “Utilizing the R100 capsid and a unique, dual-mechanism of action, 4D-150 has the potential to provide long-term benefits for patients with wet AMD after a single-dose of intravitreal anti-angiogenic gene therapy.”

The Phase 1/2 clinical trial is a dose-escalation and randomized, controlled, masked expansion trial of intravitreal 4D-150 and is expected to enroll approximately 60 adults with wet AMD. In the dose-escalation phase, multiple dose levels of 4D-150 will be examined in an open-label, 3+3 design with an initial dose of 3E10 vg/eye. In dose expansion, patients (n=50) will be randomized 2:2:1 to receive one of 2 dose levels of 4D-150 (n=20 for each dose level) or aflibercept (n=10). The primary endpoints of the study are safety and tolerability. Secondary endpoints include the number of supplemental aflibercept injections received and change from baseline in best corrected visual acuity (BCVA) over time.

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