MapLight Launches Phase 2 Study of Novel M1/M4 Agonist for Alzheimer’s Psychosis

MapLight Therapeutics has initiated the Phase 2 VISTA study of ML-007C-MA, its investigational M1/M4 muscarinic receptor agonist, as a potential treatment for Alzheimer’s disease psychosis (ADP).

Why It Matters

• Unmet need: No FDA-approved therapies exist for ADP.
• Current options: Off-label antipsychotics are used, but their limited efficacy and safety risks often worsen patient outcomes.
• Disease burden: Psychosis affects up to 40% of Alzheimer’s patients, worsening cognitive decline, driving earlier institutionalization, and raising mortality risk.

The VISTA Study

• Design: Randomized, double-blind, placebo-controlled.
• Dose: Twice-daily ML-007C-MA.
• Patients: ~300 enrolled globally.
• Primary endpoint: Change in NPI-C Hallucinations & Delusions score at Week 7.

The study builds on results from a 270-participant Phase 1 program, including 42 elderly volunteers who tolerated the drug well and reached CNS exposure levels expected to be clinically meaningful.

How ML-007C-MA Works

• Formulation: Extended-release, fixed-dose oral therapy.
• Mechanism: Activates M1 and M4 muscarinic receptors in the CNS.
• Co-formulation: Includes a peripherally acting anticholinergic (PAC) to reduce unwanted side effects.
• Promise: Designed to be well-tolerated, convenient, and capable of improving hallucinations and delusions linked to ADP.

What MapLight Says

“Muscarinic receptor agonism has shown promising results for ADP. The VISTA study is a milestone as we pursue ML-007C-MA in schizophrenia, ADP, and other neuropsychiatric conditions.”

• Christopher Kroeger, M.D., M.B.A., CEO and founder.

“The favorable safety and tolerability profile seen in elderly volunteers gives us confidence ML-007C-MA can advance as a strong candidate.”

• Erin Foff, M.D., Ph.D., Chief Medical Officer.

About MapLight

MapLight Therapeutics is a clinical-stage biopharma developing novel therapies for central nervous system disorders. Its focus is on reimagining treatment for neuropsychiatric and neurodegenerative conditions where current options fall short.

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