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, August 18, 2022 – 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.
About MapLight Therapeutics
MapLight Therapeutics is a biopharmaceutical company that discovers and develops novel therapeutics for patients with disorders of the central nervous system (CNS). MapLight’s mission is to address the critical unmet medical needs of these patients by developing innovative, targeted therapies to treat the defining clinical manifestations of their disease. The company’s circuit-based approach and proprietary discovery platform is designed to bring more effective and safer treatments to these patients by rationally developing therapies that target defective brain circuits. The company’s platform, which includes STARmap (three-dimensional spatial transcriptomics) and optogenetics, enables the identification of circuit-specific targets and validation that target modulation ameliorates disease.. Learn more at www.maplightrx.com.
Media Contact for MapLight Therapeutics