Posted by Michael Wonder on 19 Dec 2017
Stealth BioTherapeutics granted fast track designation for elamipretide for the treatment of Leber’s hereditary optic neuropathy
18 December 2017 - Stealth BioTherapeutics today announced that the U.S. FDA has granted fast track designation for its lead candidate, elamipretide, for the treatment of Leber’s hereditary optic neuropathy.
In June 2016, Stealth announced the initiation of ReSIGHT, a Phase 2, prospective, double-masked, vehicle-controlled clinical study to evaluate the safety, tolerability and efficacy of topical eye drop delivery of elamipretide in people with Leber’s hereditary optic neuropathy.
Top-line results from the study are expected by mid-2018.
