MPLT News & Events

MapLight Therapeutics announced an update to the expected timing of topline results for its ongoing Phase 2 ZEPHYR and IRIS clinical studies, which are progressing ahead of schedule. The company's Phase 2 ZEPHYR trial evaluating ML-007C-MA for the treatment of schizophrenia continues to enroll robustly, and topline results are now expected in the third quarter of 2026. The ZEPHYR study is a randomized, double-blind, placebo-controlled trial that is expected to enroll 300 hospitalized adult participants with schizophrenia experiencing acute exacerbation of psychosis. In addition, following completion of enrollment in the Phase 2 IRIS trial for ML-004 in autism spectrum disorder, topline results for that study are now expected in the third quarter of 2026. The IRIS study is a double-blind, placebo-controlled trial that randomized approximately 160 adult and adolescent participants.

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.

SandboxAQ and MapLight Therapeutics announced that the companies have entered into a strategic collaboration to discover and develop potential first-in-class therapies targeting a novel G protein-coupled receptor, GPCR, for the treatment of central nervous system, CNS, disorders. Under the terms of the agreement, SandboxAQ received an upfront payment and will be eligible to receive additional preclinical, development, regulatory, and commercial milestone payments of up to $200M in aggregate. The companies will jointly conduct preclinical research activities and MapLight will have exclusive rights for potential clinical development and commercialization of collaboration compounds. "We are excited to advance research efforts for this novel target that was identified and validated using our discovery platform," said James Lillie, Chief Scientific Officer at MapLight. "We look forward to collaborating with SandboxAQ to leverage their AI platform to discover and advance novel therapies that have the potential to address significant unmet patient needs across a spectrum of CNS conditions."