Posted by Michael Wonder on 21 Oct 2020
U.S. FDA grants fast track designation for ASP0367/MA-0211, a selective PPARδ modulator being developed for the treatment of primary mitochondrial myopathies
20 October 2020 - Astellas Pharma today announced that the U.S. FDA has granted fast track designation for the development of ASP0367/MA-0211 as a potential treatment for primary mitochondrial myopathies.
Pre-clinical data and results from Astellas’ Phase I healthy volunteer study collectively suggest that ASP0367 - an orally administered PPARδ modulator - could improve exercise intolerance and fatigue in patients with primary mitochondrial myopathy by increasing the number and enhancing the function of mitochondria in patient’s cells.
ASP0367 will be entering a Phase 2/3 clinical trials (MOUNTAINSIDE) to validate the efficacy and safety in patients with a primary mitochondrial myopathy.
