Posted by Michael Wonder on 07 Jan 2021
Gemini Therapeutics announces FDA fast track designation granted for GEM103 for the treatment of dry age-related macular degeneration in patients with complement factor H loss of function gene variants
7 January 2020 - Gemini Therapeutics today announced that GEM103, the Company’s investigational treatment for dry age-related macular degeneration, has been granted fast track designation by the United States FDA.
Gemini is evaluating GEM103, a recombinant, human complement factor H (CFH), for its ability to address the multiple age-related macular degeneration pathobiologies in genetically-defined subsets of age-related macular degeneration patients caused by CFH loss-of-function variants and slow the progression of their disease. CFH loss-of-function variants are present in approximately 40% of patients with age-related macular degeneration.
The ongoing Phase 2a ReGAtta trial is evaluating GEM103 in patients with geographic atrophy secondary to dry age-related macular degeneration.
