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

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." 

The Phase 1 single ascending dose clinical trial for ML-007 enrolled 58 healthy adult volunteers aged 18 to 45 across 7 cohorts. Six cohorts received escalating oral doses of ML-007, successfully providing data to identify a maximum tolerated dose of the single agent. Subjects in a seventh cohort received ML-007 ­­­­­­­in combination with a peripherally restricted muscarinic antagonist, which was well tolerated and without severe or serious adverse events.

MapLight Therapeutics is developing targeted, highly effective therapeutics to improve the lives of those with difficult-to-treat brain disorders. Today, there are few therapeutic options for people living with conditions such as Autism Spectrum Disorder, Parkinson's Disease, and Schizophrenia, and those therapies are limited by modest efficacy and significant side effects. MapLight is committed to redefining this standard of care. The company's unique discovery platform combines novel, proprietary technologies to uncover the individual circuits that misfire in brain disorders and treat those circuits with effective, safe therapeutics. MapLight was founded in 2019 by a team of renowned neuroscientists who led the discovery of such groundbreaking technologies as optogenetics and STARmap. Learn more at www.maplightrx.com.                                                                                                                      

Media Contact for MapLight Therapeutics
Lauren Davis, Alkali Marketing, 512-751-2946

SOURCE MapLight Therapeutics, Inc.