First patient dosed in trial of dual-transgene intravitreal gene therapy for wet AMD
The first patient has been dosed in a phase 1/2 clinical trial investigating 4D-150 for the treatment of wet age-related macular degeneration, according to a press release from 4D Molecular Therapeutics.
“4D-150 is a dual-transgene intravitreal gene therapy incorporating the R100 capsid, which we invented through our proprietary Therapeutic Vector Evolution platform,” David Kirn, MD, co-founder and CEO of 4DMT, said in the release.
The company anticipates enrolling 60 adults in the dose-escalation, randomized, controlled, masked expansion trial.
In the dose-escalation phase, participants will receive an initial dose of 3E10 vg per eye, with multiple doses under examination. In the dose-expansion phase, 50 participants will be randomly assigned 2:2:1, with 20 participants each receiving one of two dose levels of 4D-150 and 10 participants receiving aflibercept.
Primary endpoints are safety and tolerability, while secondary endpoints include the number of additional aflibercept injections and change from baseline in best corrected visual acuity over time.
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