MapLight Receives FDA Fast Track Designation for ML-007C-MA

MapLight Therapeutics announced that the U.S. Food and Drug Administration has granted Fast Track designation to ML-007C-MA, an investigational novel M1/M4 muscarinic agonist, for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis. The Fast Track process is intended to facilitate the development and expedite the review of investigational therapies for serious conditions with unmet medical need. A drug with Fast Track designation may be eligible for more frequent interactions with the FDA, as well as accelerated approval and priority review, if applicable criteria are met. "FDA's Fast Track designation underscores the significant unmet need of the millions of people with Alzheimer's disease psychosis with no currently approved treatment options," said Erin Foff, M.D., Ph.D., Chief Medical Officer of MapLight. "This designation is an important milestone for the ML-007C-MA program that recognizes its potential to address the psychotic symptoms that frequently accompany the cognitive decline in people living with Alzheimer's disease. We remain committed to working closely with the FDA to advance this program expeditiously through our ongoing Phase 2 VISTA study." In a Phase 1 clinical trial, ML-007C-MA demonstrated a generally favorable safety and tolerability profile with twice daily dosing in healthy elderly participants. Enrollment is currently ongoing in the Phase 2 VISTA study, a randomized, double-blind, placebo-controlled trial evaluating ML-007C-MA for the treatment of hallucinations and delusions associated with ADP. MapLight expects to enroll 300 participants in the trial and report topline results in the second half of 2027.