MAPLIGHT THERAPEUTICS ANNOUNCES COMPLETION OF PHASE 1 CLINICAL TRIAL FOR ML-007, A NOVEL THERAPY FOR THE TREATMENT OF SCHIZOPHRENIA AND DYSKINESIAS
First in human study demonstrates positive safety and tolerability profile for MapLight’s M1/M4 muscarinic agonist therapy
Excerpt from the Press Release:
SAN FRANCISCO, Aug. 18, 2022 /PRNewswire/ — MapLight Therapeutics today announced it has completed its Phase 1 clinical trial evaluating ML-007, the second clinical compound developed using the MapLight platform. ML-007 is an M1/M4 muscarinic agonist that targets circuits thought to be disrupted in neurologic conditions such as schizophrenia and dyskinesia. ML-007 was studied in a randomized, double blind, placebo-controlled single ascending dose trial to evaluate its safety, tolerability, pharmacokinetic, and pharmacodynamic profile.
ML-007 was well-tolerated with no serious adverse events. The compound produced the predicted peripheral effects of muscarinic activation, demonstrating on-target activity, and these effects were dose limiting as expected. Co-treatment with a peripherally-restricted anticholinergic was effective in blocking objective measures of peripheral muscarinic symptoms. The pharmacokinetics of ML-007 were favorable with fast absorption, dose-proportional exposure, and low inter-subject variability. Target CSF concentrations were achieved at well tolerated doses.
The successful completion of our ML-007 Phase 1 clinical trial is a major milestone for MapLight,” stated Christopher Kroeger, M.D., MBA, Chief Executive Officer and Founder. “This study is a significant step forward for our M1/M4 muscarinic agonist program, a program that we believe will yield a best in class therapy for patients suffering with schizophrenia and dyskinesia.”
Click the button below to read the entire Press Release:
Discover What Sets TrialStat Apart From Ordinary EDC Platforms
Click the image or button below to explore our eClinical Suite Platform and discover what sets TrialStat apart from competing EDC platforms.
Request Your Demo Today!
From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?