MP101 / Mitochon Pharma - LARVOL DELTA

European Medicines Agency (EMA) Greenlights Mitochon Pharmaceuticals to Initiate Phase I/IIa Biomarker Study in Neurodegenerative Diseases (Yahoo Finance) - "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."

New P1/2 trial • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Huntington's Disease

[VIRTUAL] Protonophore Amelioration in Huntington’s, Parkinson’s and MS Models, plus Emerging ALS Data: MP101 & prodrug MP201 (NDS 2021) - No abstract available

CNS Disorders • Huntington's Disease • Movement Disorders • Parkinson's Disease

Disease modifying mitochondrial uncouplers, MP101, and a slow release ProDrug, MP201, in models of Multiple Sclerosis. (PubMed, Neurochem Int) - "This would be a completely novel treatment for MS, targeting the mitochondria directly using a unique platform, mitochondrial uncouplers, that initially act non-genomically based upon biophysics, but cascades into cellular remodeling, neuroprotection and pro-survival. Clinical Phase I testing of MP101 in Normal Healthy Volunteers (NHV) is currently underway allowing for the potential to subsequently evaluate translation in MS patients and other insidious diseases, at expected weight neutral doses."

Journal • CNS Disorders • Immunology • Metabolic Disorders • Multiple Sclerosis

Protonophore Amelioration in Huntington’s,Parkinson’s and MS Models plus Emerging ALS Data: MP101 & prodrug MP201 (NDS 2020) - No abstract available

CNS Disorders • Gene Therapies • Genetic Disorders • Movement Disorders • Parkinson's Disease

A Study of MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression (clinicaltrials.gov) - P2; N=84; Active, not recruiting; Sponsor: Mediti Pharma Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Aug 2020 ➔ Feb 2020; Trial primary completion date: Aug 2020 ➔ Feb 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date

A Study of MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression (clinicaltrials.gov) - P2; N=84; Terminated; Sponsor: Mediti Pharma Inc.; Active, not recruiting ➔ Terminated; Statistical futility; totality of evidence suggests study unlikely to meet endpoint

Clinical • Trial termination

A Study of MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Mediti Pharma Inc.; Trial completion date: Jan 2021 ➔ Aug 2020; Trial primary completion date: Jan 2021 ➔ Aug 2020

Clinical • Trial completion date • Trial primary completion date