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.
