Maplight Therapeutics Launches Phase 1 Trial for ML-007/PAC in Schizophrenia and Alzheimer's Psychosis

MapLight Therapeutics has initiated a Phase 1 clinical trial for ML-007/PAC, a novel combination therapy aimed at treating schizophrenia and Alzheimer's disease psychosis. The study will assess the safety, tolerability, and pharmacokinetics of the extended-release drug in both younger and older healthy adults. The trial is a continuation of previous research on the muscarinic agonist ML-007, which has shown promising results in three prior Phase 1 trials when co-administered with a peripherally active anticholinergic (PAC).
Christopher Kroeger, CEO and Founder of MapLight, expressed satisfaction with the progress of the ML-007 program and highlighted the favorable tolerability observed in adults, including the elderly. The data from this trial will guide the dosing regimen for the upcoming Phase 2 trials. John Kane, M.D., from the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, emphasized the significant unmet need in schizophrenia treatment, with a majority of patients not fully responding to current treatments. He anticipates that muscarinic receptor agents, like ML-007, could significantly improve schizophrenia treatment options.
ML-007 targets M1 and M4 muscarinic receptor subtypes, which are linked to schizophrenia and important for neural circuits involved in psychosis and cognition. ML-007/PAC is designed to maximize the therapeutic potential of ML-007 by synchronizing the pharmacokinetics of its components without compromising the activation of M1 and M4 receptors.
Schizophrenia is a severe mental illness with a significant portion of patients not responding adequately to standard treatments. Alzheimer's disease psychosis affects about 40% of diagnosed individuals in the U.S., with no FDA-approved therapies currently available. MapLight Therapeutics, founded by leaders in psychiatry and neuroscience, is dedicated to developing targeted therapies for CNS disorders, utilizing a discovery platform that identifies and targets disease-linked neural circuits. The company's goal is to address the gap in circuit-specific pharmacotherapies for patients.

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