MAPLIGHT THERAPEUTICS ANNOUNCES COMPLETION OF PHASE 1 CLINICAL TRIAL FOR ML-007, A NOVEL THERAPY FOR THE TREATMENT OF SCHIZOPHRENIA AND DYSKINESIAS

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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.”

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