European Medicines Agency (EMA) Greenlights Mitochon Pharmaceuticals to Initiate Phase I/IIa Biomarker Study in Neurodegenerative Diseases
Blue Bell, Pennsylvania (BUSINESS WIRE) — Mitochon Pharmaceuticals today announced that it was awarded approval from EMA to begin enrollment for a Phase I/IIa biomarker study in Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Huntington’s Disease (HD) and Alzheimer’s Disease (AD) participants. Mitochon’s MP101, a once-daily, oral brain penetrant mitochondrial stimulator, that improves central nervous system survival and function will be used in this 14-day pilot study. The aim of the study is to show safety in the target patient populations and demonstrate meaningful changes in disease specific biomarkers. Successful completion of this study will provide the basis for long term Phase IIb clinical studies in ALS, Secondary & Primary Progressive MS, HD, and AD patients, leading to the first mitochondrial specific therapy for these truly insidious diseases.
“We are delighted for the opportunity to explore this provocative idea that most, if not all neurodegenerative diseases are rooted in mitochondrial dysfunction. We predict that chronic treatment with this unique platform, at micro-doses, will resolve mitochondrial issues and change important disease specific biomarkers in all four indications similarly,” said Dr. John G. Geisler, Ph.D., co-founder and CSO of Mitochon.