FDA clears 4D Molecular’s IND Application for 4D-175 for GA treatment

4D Molecular Therapeutics announced U.S. Food and Drug Administration or FDA, clearance of the Investigational New Drug Application or IND, for 4D-175, an R100 vector-based intravitreal genetic medicine, for the treatment of patients with GA.The Phase 1 GAZE clinical trial will assess 4D-175 in patients with GA secondary to AMD. The study design consists of an open-label, sequential cohort Dose Exploration stage, in which patients will receive a single intravitreal injection of 4D-175 at one of three dose levels. Clinical trial objectives include safety and tolerability, definition of the Phase 2 trial dose level , transgene expression and biological activity. The IND clearance enables the initiation of GAZE clinical study sites, and 4DMT expects to begin enrollment in H2 2024. “GA is a leading cause of irreversible vision loss for over 5 million people globally and while current bolus complement inhibitor treatments reduce the rate of growth in GA lesions, they require burdensome monthly or bimonthly intravitreal injections and do not demonstrate functional vision benefit,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “4D-175 has the potential for durable clinical benefit with a single intravitreal injection, greatly reducing the current treatment burden for patients, which may lead to better long-term vision outcomes. In Phase 1, we aim to explore safety and transgene expression levels to select doses for Phase 2. We look forward to beginning enrollment in the Phase 1 GAZE clinical trial in the second half of 2024.”