Gyroscope Therapeutics Granted FDA Fast Track Designation for Investigational Gene Therapy for Dry AMD

Fast Track designation was granted to GT005 for the treatment of people with GA who have specific mutations in their Complement Factor I (CFI) gene and low levels of the CFI protein in their blood. Enrollment in the phase 2 EXPLORE study [NCT04437368] to evaluate GT005 in this group of people is underway.

“Dry AMD is a life-altering diagnosis and there are currently no FDA-approved medicines available. 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,”¹ Nadia Waheed, MD, MPH, Chief Medical Officer, said in a company news release. “We are pleased to receive Fast Track designation for our investigational gene therapy for this high-risk group. We look forward to working with the FDA as we advance our clinical program evaluating the safety and effectiveness of GT005.”

In addition to EXPLORE, Gyroscope also plans to initiate a second phase 2 trial in 2020 that will evaluate GT005 in a broader group of people with GA.

The FDA’s Fast Track program streamlines the review of drugs for serious conditions without FDA-approved treatment options available. 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.