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4D Molecular Therapeutics (4DMT) announced that the first patients have been enrolled across multiple sites in the 4FRONT-1 phase 3 clinical trial evaluating 4D-150 for the treatment of wet age-related macular degeneration (AMD).
"This is a historic moment for 4DMT as we become a phase 3 company following our initiation of the 4FRONT-1 clinical trial,” David Kirn, MD, Co-founder and Chief Executive Officer of 4DMT, said in a company news release. “4D-150 has the clear potential to address the greatest unmet needs for the millions of patients with wet AMD and DME: multi-year relief from frequent and burdensome injections into the eye and preservation of their eyesight. We believe the design of the 4FRONT phase 3 trials, the design of 4D-150 itself and the compelling clinical data generated to date position us for a successful product approval and commercialization. As a result of our innovation, 4D-150 has the potential to become the established durable backbone therapy for these diseases and to fit seamlessly into clinical practice and economic models for retina physicians.”
4FRONT-1 is a phase 3 multicenter, randomized, double-masked, aflibercept 2 mg (Q8W) comparator-controlled study of intravitreal 4D-150 in wet AMD. The primary endpoint is noninferiority in the mean change from baseline in best corrected visual acuity (BCVA) at 52 weeks. The key secondary endpoint is treatment burden reduction comparing the number of aflibercept injections received in the 4D-150 arm versus the aflibercept comparator arm over 52 weeks. Patients in both arms will be eligible for supplemental aflibercept injections. 4FRONT-1 is evaluating treatment naïve wet AMD patients at sites in North America. The company's second phase 3 trial for wet AMD, 4FRONT-2, has an identical design to 4FRONT-1 but will evaluate 4D-150 in both treatment naïve and recently diagnosed, treatment experienced wet AMD patients globally. 4FRONT-2 is expected to initiate in Q3 2025. Topline primary endpoint data from both trials is expected in the second half of 2027.
"As an investigator in the PRISM phase 1/2 study with 4D-150, I’ve had the opportunity to see firsthand its potential to alter the course of the disease and reduce the treatment burden for patients with wet AMD," said Arshad M. Khanani, MD, MA, FASRS, Chair of the 4DMT Ophthalmology Advisory Board and a principal investigator of the 4FRONT-1 clinical trial. "I’m thrilled to participate in the 4FRONT-1 trial and look forward to collaborating with the dedicated team at 4DMT and my fellow investigators to potentially bring 4D-150 to patients with wet AMD, with the chance to make a lasting difference in their lives."
4D-150 is designed to provide multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) from the retina with a single intravitreal injection. It utilizes 4DMT's customized intravitreal vector, R100, which was invented at 4DMT through its proprietary Therapeutic Vector Evolution platform. 4D-150 is being developed for wet AMD and diabetic macular edema.
Maria Berrocal, MD and Audina Berrocal, MD
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