MAPLIGHT THERAPEUTICS ANNOUNCES COMPLETION OF PHASE 1 CLINICAL TRIAL FOR NOVEL M1/M4 MUSCARINIC AGONIST IN DEVELOPMENT FOR SCHIZOPHRENIA AND ALZHEIMER’S DISEASE PSYCHOSIS

• Extended-release ML-007 was evaluated for safety, tolerability, and pharmacokinetic profile in healthy volunteers across several dosing regimens, alone and when co-administered with an extended-release muscarinic antagonist
  
• Extended-release ML-007 was well tolerated at all doses including doses at and above those planned for use in the company’s upcoming Phase 2 trials for the treatment of schizophrenia and Alzheimer’s disease psychosis
  
• Pharmacokinetic data demonstrated precise matching of the kinetics of ML-007 with that of the peripheral antimuscarinic, and this close kinetic match correlated with improved tolerability
  
• Treatment-emergent adverse events were uncommon, and all were mild and transient with no serious adverse events observed
  
• MapLight plans to advance ML-007C-MA, a fixed-dose combination tablet formulation of ML-007 and its precision-matched muscarinic antagonist, to Phase 2 clinical trials in 2024

Excerpt from the Press Release:

SAN FRANCISCO AND BOSTON, Jan. 3, 2024 /PRNewswire/ — MapLight Therapeutics, a clinical-stage biopharmaceutical company working to develop targeted novel therapeutics to improve the lives of people with brain disorders, today announced completion of a Phase 1 clinical trial evaluating the bioavailability, safety, and tolerability of an extended release formulation of ML-007, a novel M₁/M₄ preferring muscarinic agonist, alone and when co-administered with a precision-matched muscarinic antagonist designed to offset peripheral effects. The study included 24 healthy volunteers across three cohorts and assessed the drug’s safety, tolerability, and pharmacokinetic profile when dosed using twice-daily and once-daily dosing regimens. This is the company’s third Phase 1 study of ML-007, and the first to evaluate the extended-release formulation developed for the treatment of chronic conditions.

Extended-release ML-007 was well tolerated in this trial at all doses, including those planned for use in the company’s upcoming Phase 2 clinical trials for the treatment of schizophrenia and Alzheimer’s disease psychosis. Plasma exposures at or above anticipated clinically relevant levels were maintained over the duration of the intended dosing interval. The plasma concentration ratios of ML-007 ER and its matched muscarinic antagonist remained within target range at anticipated clinically relevant doses and were associated with excellent tolerability. Treatment-emergent adverse events were uncommon, and all were mild and transient. No serious adverse events nor any unexpected or novel adverse events were observed with ML-007 administration in this study or in prior studies. Findings from this study will enable formulation optimization of ML-007C-MA, the fixed-dose combination of ML-007 and its matched muscarinic antagonist, allowing the company to move ML-007C-MA into Phase 2 clinical trials later this year.

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