MapLight Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of novel therapeutics for brain disorders. It develops the ML-007-MA product for treatment of schizophrenia and ADP. Its platforms include Optogenetics, Transcriptnomics, and STARmap. The company was founded by Christopher A. Kroeger, Karl Deisseroth, Robert Malenka, and Karoly Nikolich in November 2018 and is headquartered in Redwood City, CA.
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- MapLight Therapeutics announced that the FDA has granted Fast Track designation to ML-007C-MA, an investigational M1/M4 muscarinic agonist for treating hallucinations and delusions in Alzheimer's disease psychosis. - The designation facilitates expedited development and review for this serious condition affecting approximately 40% of Alzheimer's patients, with no currently approved treatment options available. - ML-007C-MA demonstrated favorable safety and tolerability in Phase 1 trials, with enrollment ongoing in a Phase 2 VISTA study expected to report topline results in the second half of 2027.
- MapLight Therapeutics has launched the Phase 2 ZEPHYR study to evaluate ML-007C-MA, a novel M1/M4 muscarinic agonist, for treating schizophrenia in approximately 300 patients across the United States. - The randomized, double-blind, placebo-controlled trial will assess once- and twice-daily dosing regimens with the primary endpoint measuring changes in PANSS total scores from baseline to Week 5. - ML-007C-MA demonstrated favorable safety and tolerability in Phase 1 studies involving 270 healthy volunteers, with minimal titration requirements and no fasting restrictions while achieving clinically relevant CSF exposures. - The drug targets the significant unmet medical need in schizophrenia treatment, a disorder affecting over 20 million people worldwide and recognized as a leading cause of disability.
• Over 120 Alzheimer's Disease treatment therapies are under development by 110+ companies globally, ranging from preclinical to marketed phases. • Emerging therapies like NRDN-201, ST-501, and KarXT are in various clinical trial phases, showing potential for significant market impact. • MapLight Therapeutics initiated a Phase 1 trial for ML-007/PAC, targeting schizophrenia and Alzheimer's disease psychosis, with Phase 2 trials planned. • The FDA granted conventional approval to Leqembi (lecanemab-irmb), marking the first amyloid beta-directed antibody to transition from accelerated approval.
- Over 120 Alzheimer's Disease treatment therapies are under development globally, targeting various mechanisms of action and routes of administration. - Gene therapy is emerging as a potential treatment strategy, with over 300 gene therapy drugs in the pipeline for various diseases, including neurological disorders. - Several companies are advancing Alzheimer's therapies through clinical trials, including Phase 3 studies for small molecule candidates and Phase 1 trials for novel muscarinic agonists. - Recent FDA approval of Leqembi marks a significant milestone, highlighting the potential of amyloid beta-directed antibodies in treating Alzheimer's disease.
