4D Molecular To Test Its Wet AMD Gene Therapy In Patients
Benzinga
Oct. 6, 2021, 08:27 AM
- The FDA has signed off 4D Molecular Therapeutics' (NASDAQ:FDMT) Investigational New Drug Application (IND) for 4D-150 for wet age-related macular degeneration (wet AMD).
- The active IND enables the initiation of a 4D-150 Phase 1/2 clinical trial, expected before year-end.
- 4D-150 is a dual-transgene intravitreal gene therapy encompassing the R100 capsid, invented through Therapeutic Vector Evolution.
- The Phase 1/2 clinical trial is a dose-escalation and randomized, controlled, masked expansion trial of intravitreal 4D-150.
- The trial will enroll approximately 60 adults with wet AMD.
- 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.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: FDMT stock is up 3.67% at $27.00 during the premarket session on the last check Wednesday.
