Posted by Michael Wonder on 10 Dec 2018
Stealth BioTherapeutics granted fast track designation for elamipretide for the treatment of dry age-related macular degeneration with geographic atrophy
10 December 2018 - Stealth BioTherapeutics today announced that the U.S. FDA has granted fast track designation for its lead investigational candidate, elamipretide, for the treatment of dry age-related macular degeneration with geographic atrophy.
In November 2016, Stealth announced the initiation of ReCLAIM, an open-label Phase 1 study to evaluate the safety and tolerability of 24 weeks' treatment with daily subcutaneous injections of elamipretide in patients with dry AMD. In early 2019, Stealth plans to initiate a Phase 2b, randomized, double-masked, placebo-controlled clinical study to evaluate the safety and efficacy of subcutaneous injections of elamipretide in patients with dry AMD with geographic atrophy.
