MapLight Therapeutics announces initiation of Phase 1 Clinical Trials for novel therapy to treat patients with Schizophrenia or Dyskinesias

Initial study is enrolling healthy patients across seven cohorts to assess safety, tolerability, and pharmacokinetic profile related to ML-007 therapy

SAN FRANCISCO, February 2, 2022 – MapLight Therapeutics announced it has initiated a Phase 1 clinical trial evaluating ML-007, a novel therapeutic developed to target circuits understood to be dysfunctional in neurologic conditions such as schizophrenia and dyskinesias. The randomized, double blind, placebo-controlled single ascending dose study will evaluate the safety, tolerability, and pharmacokinetic profile of ML-007 in up to 58 healthy adult individuals aged 18 to 45. The study is being conducted in Canada and is fully funded by MapLight.

“We are thrilled to be moving ML-007 into the clinic,” stated Christopher Kroeger, M.D., MBA, Chief Executive Officer and Founder. “We believe this therapy has great potential to improve the lives of patients with complex neurological disorders such as dyskinesias and schizophrenia.”

ML-007 is a novel M1/M4 muscarinic agonist that acts on neurons in the basal ganglia. By utilizing a mechanism independent of the dopamine receptor, ML-007 is designed to bypass the problematic adverse effects associated with direct dopamine receptor actions. The trial is expected to complete enrollment in the first quarter of 2022.

“Currently available therapeutic options do not address the needs of patients suffering from the debilitating impacts of dyskinesias and schizophrenia, and are often encumbered by intolerable side effects,” relates MapLight Chief Medical Officer, Erin Pennock Foff, M.D., Ph.D. “This study will generate crucial data that will inform further development of ML-007, and is an exciting first step in exploring the potential of this compound.”

About ML-007

ML-007 is the second clinical program to emerge from the MapLight platform. The platform enables investigation of the specific circuits that misfire in brain disorders and identifies highly targeted therapeutics to treat them. The company is developing ML-007 for multiple indications, including schizophrenia and dyskinesia.

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

Lauren Davis,
Alkali Marketing