MP-101 / Eli Lilly, Mediti - LARVOL DELTA

Clinical investigations of compounds targeting metabotropic glutamate receptors. (PubMed, Pharmacol Biochem Behav) - "PET ligands for mGlu5Rs have been studied in a range of patient populations and several mGlu5R antagonists have been tested for potential efficacy in patients including mavoglurant, diploglurant, basimglurant, GET 73, and ADX10059...Fenobam was approved for use as an anxiolytic prior to its recognition as an mGlu5R antagonist. mGlu2/3R agonists (pomaglumated methionil) and mGlu2R agonists (JNJ-40411813, AZD 8529, and LY2979165) have been studied in patients with schizophrenia with promising but mixed results. Antagonists of mGlu2/3Rs (decoglurant and TS-161) have been studied in depression where TS-161 has advanced into a planned Phase 2 study in treatment-resistant depression...The mGlu4R potentiator, foliglurax, did not meet its primary endpoint in patients with Parkinson's disease. Ongoing efforts to develop mGluR-targeted compounds continue to promise these glutamate modulators as medicines for psychiatric and neurological disorders."

Journal • CNS Disorders • Depression • Developmental Disorders • Epilepsy • Fragile X Syndrome • Gastroenterology • Gastroesophageal Reflux Disease • Genetic Disorders • Mental Retardation • Mood Disorders • Movement Disorders • Pain • Parkinson's Disease • Psychiatry • Schizophrenia

A Study of MP-101 in the Treatment of Psychosis in Alzheimer's Disease (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Mediti Pharma Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • Biosimilar

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

Better Living through molecular neuropharmacology (Genengnews) - "Scherz reports that the company has been given the green light from the FDA to conduct a Phase II trial of MP-101 based on existing safety data obtained from studies of the original 1:1 ratio dimiracetam. All Metys Pharmaceuticals needs now, he says, is funding...The Phase II PIONEER study (Prospective Therapy to Inhibit and Overcome Alzheimer’s Disease Neurodegeneration via Brain EnErgetics and Metabolism Restoration) is expected to enroll up to 252 adults with mild-to-moderate AD, beginning in early 2020."

New P2 trial • Trial status

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

Mitochon Pharmaceuticals awarded Orphan Drug Designation (Businesswire) - “Mitochon Pharmaceuticals today announced that it was awarded Orphan Drug Designation by FDA for its mitochondrial targeted compound, MP-101 for treating Huntington’s Disease.…Mitochon will initiate Phase I studies in normal healthy volunteers in 2019 and expected to be in Phase II studies in 2020.”

New P1 trial • New P2 trial • Orphan drug