MapLight Completes Phase 1 Trial for M1/M4 Muscarinic Agonist in Schizophrenia and Alzheimer's Psychosis

In a recent development, MapLight Therapeutics, a biopharmaceutical firm focused on brain disorder treatments, has successfully completed a Phase 1 clinical trial for an innovative medication. The drug in question, ML-007, is an M1/M4 preferring muscarinic agonist designed to target specific receptors associated with schizophrenia and Alzheimer's disease psychosis. The trial aimed to evaluate the safety, tolerability, and pharmacokinetic profile of an extended-release version of ML-007, both in isolation and in conjunction with a muscarinic antagonist to mitigate peripheral side effects.

The study involved 24 healthy participants and assessed the drug's performance under various dosing schedules. Notably, ML-007 showed excellent tolerability at all tested doses, which included levels exceeding those projected for the subsequent Phase 2 trials. The pharmacokinetic data revealed a precise correlation between ML-007 and the peripheral antimuscarinic, which contributed to the drug's enhanced tolerability. Importantly, adverse events were rare, mild, and short-lived, with no serious incidents reported.

The positive outcomes of this trial have paved the way for the advancement of ML-007C-MA, a fixed-dose combination of ML-007 and its muscarinic antagonist, into Phase 2 trials scheduled for 2024. The company's leadership, including CEO and Founder Christopher Kroeger, expressed optimism about the potential of this new class of muscarinic receptor agents to significantly improve upon current treatments. They highlighted the achievement of target exposure levels and the favorable tolerability profile as key advancements.

MapLight's Chief Medical Officer, Erin Pennock Foff, emphasized the significant unmet needs in the treatment of schizophrenia and Alzheimer's disease psychosis, conditions that affect large patient populations and present a considerable challenge to the healthcare system. The study's findings are expected to guide the dosing strategy for ML-007C-MA in the upcoming trials, bringing the company closer to offering a superior treatment option for these debilitating conditions.

ML-007 is unique in its approach, targeting M1 and M4 muscarinic receptor subtypes without directly affecting dopamine receptors. The M1 receptor's deficit is linked to schizophrenia, and it plays a crucial role in neural circuits involved in psychosis and cognition. Similarly, the M4 receptor modulates a neural circuit important for psychosis.

MapLight Therapeutics is dedicated to developing precise and effective treatments for challenging brain disorders. The company's discovery platform is built on proprietary technologies that identify and target the specific brain circuits disrupted in these disorders. Founded by a team of distinguished neuroscientists, MapLight is at the forefront of brain disorder research and innovation.