Gyroscope Therapeutics initiates phase 2 trial of GT005 in geographic atrophy
Gyroscope Therapeutics has begun a phase 2 program to evaluate GT005, an investigational gene therapy for the treatment of geographic atrophy secondary to dry age-related macular degeneration, according to a press release.
EXPLORE is a multicenter, randomized trial that aims to evaluate the safety and efficacy of a single subretinal injection of GT005. Patients aged 55 years or older with a clinical diagnosis of geographic atrophy and a mutation of the CFI gene are being enrolled in the study. The trial will have three arms consisting of two different doses of GT005 or control.
Details of a second trial, also planned for this year, in a broader patient population will be released at a later date.
GT005 works to balance an overactive complement system by increasing production of complement factor I protein, the release said. An overactive complement system may play a role in AMD development.
“Research suggests GT005 may be best suited for people with certain mutations in their CFI gene. However, evidence also suggests it may have potential for a broader population of people with geographic atrophy,” Nadia Waheed, MD, MPH, chief medical officer of Gyroscope, said in the release.