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.”