Gyroscope Therapeutics Limited has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to GT005 for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The FDA’s Fast Track programme streamlines the review of drugs for serious conditions without FDA-approved treatment options available.
GT005 is an investigational one-time AAV-based gene therapy delivered under the retina that aims to slow the progression of GA. It is designed to restore balance to an overactive complement system by increasing the production of the Complement Factor I protein. The therapy is intended for people with GA who have specific mutations in their Complement Factor I (CFI) gene and low levels of the CFI protein in their blood.
GT005 is currently being evaluated in a Phase I/II clinical trial called FOCUS and a Phase II clinical trial called EXPLORE [NCT04437368]. The first patient in the Phase II trial has been dosed this past August.
“Dry AMD is a life-altering diagnosis and there are currently no FDA-approved medicines available,” said Nadia Waheed, M.D., MPH, Chief Medical Officer. “Research suggests people with dry AMD who have certain CFI mutations that correlate with low CFI levels in the blood have a higher risk of developing AMD.”
In addition to EXPLORE, Gyroscope also plans to initiate a second Phase II trial in 2020 that will evaluate GT005 in a broader group of people with GA.
Fast Track designation gives applicants access to more frequent communication with the FDA throughout the review process, and the potential to apply for Accelerated Approval and Priority Review if relevant criteria are met, as well as Rolling Review, which means that completed sections of the Biologic License Application can be submitted for review before the entire FDA application is complete.
Read the full news release here.
Source: Gyroscope Therapeutics