ML-007/PAC / MapLight Therap - LARVOL DELTA

Business Highlights and Upcoming Milestones (GlobeNewswire) - "Topline results from Phase 2 VISTA trial for ADP expected in the second half of 2027...The Company expects to complete IND-enabling studies for ML-021 in the second half of 2026."

P2 data • Preclinical • Alzheimer's Disease • Parkinson's Disease

MapLight Therapeutics Announces Initiation of Phase 2 Trial of Novel M1/M4 Muscarinic Agonist ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis (PRNewswire) - "The Phase 2 VISTA study is a randomized, double-blind, placebo-controlled trial evaluating a twice-daily dose of ML-007C-MA for the treatment of hallucinations and delusions associated with ADP. This global study is expected to enroll approximately 300 patients. The primary endpoint of the study is the change in the Neuropsychiatric Inventory - Clinician Rating Scale Hallucinations and Delusions, or NPI-C H+D, score from baseline to Week 7."

Trial status • Alzheimer's Disease

MapLight Therapeutics Announces Initiation of Phase 2 Trial of Its Novel M1/M4 Muscarinic Agonist ML-007C-MA for the Treatment of Schizophrenia (PRNewswire) - "MapLight Therapeutics today announced the initiation of a Phase 2 study to evaluate the efficacy, safety and tolerability of ML-007C-MA, an investigational novel M1/M4 agonist, as a potential treatment for schizophrenia. The Phase 2 ZEPHYR study has been designed based on the results of an extensive Phase 1 development program that included 270 healthy volunteers...The Phase 2 ZEPHYR study is a randomized, double-blind, placebo-controlled trial evaluating once- and twice-daily doses of ML-007C-MA in adults with a primary diagnosis of schizophrenia who are experiencing an acute exacerbation or relapse of symptoms. The study is expected to enroll approximately 300 patients throughout the United States. The primary endpoint of the study is the change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 5."

Trial status • Schizophrenia

MapLight Therapeutics Announces $372.5 Million Series D Financing (PRNewswire) - "MapLight Therapeutics today announced an oversubscribed $372.5 million Series D financing...With this financing, MapLight will advance ML-007C-MA through ongoing Phase 2 trials for schizophrenia and Alzheimer's disease psychosis. The financing will also fund the exploration of other potential indications for ML-007C-MA, as well as the continued advancement of other clinical and preclinical pipeline programs."

Financing • Alzheimer's Disease • Psychiatry • Schizophrenia

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: MapLight Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • Psychiatry

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: MapLight Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Psychiatry • Schizophrenia

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: MapLight Therapeutics

New P2 trial • CNS Disorders • Psychiatry • Schizophrenia

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: MapLight Therapeutics | Initiation date: Mar 2025 ➔ Jun 2025

Trial initiation date • Alzheimer's Disease • CNS Disorders • Psychiatry

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: MapLight Therapeutics

New P2 trial • Alzheimer's Disease • CNS Disorders • Psychiatry

MAPLIGHT THERAPEUTICS ANNOUNCES RESULTS FROM PHASE 1 TRIAL OF NOVEL M1/M4 MUSCARINIC AGONIST IN DEVELOPMENT FOR TREATMENT OF SCHIZOPHRENIA AND ALZHEIMER'S DISEASE PSYCHOSIS (PRNewswire) - P1 | N=NA | "MapLight Therapeutics...today announced results from its Phase 1 trial evaluating the safety, tolerability and pharmacokinetics of ML-007/PAC in healthy adult and elderly volunteers...The company plans to initiate Phase 2 trials of ML-007/PAC in schizophrenia and Alzheimer's disease psychosis (ADP) in the first half of 2025...ML-007/PAC was generally well tolerated at the doses planned for the Phase 2 clinical trials. Most treatment-emergent adverse events (TEAEs) were mild and transient in nature. No severe or serious adverse events were observed...Pharmacokinetic parameters were similar between adult and elderly volunteers and confirmed that the dosing in the planned Phase 2 trials will not require administration in a fasted state."

New P2 trial • P1 data • Alzheimer's Disease • CNS Disorders • Schizophrenia

MAPLIGHT THERAPEUTICS ANNOUNCES COMPLETION OF PHASE 1 CLINICAL TRIAL FOR NOVEL M1/M4 MUSCARINIC AGONIST IN DEVELOPMENT FOR SCHIZOPHRENIA AND ALZHEIMER’S DISEASE PSYCHOSIS (PRNewswire) - P1 | N=NA | "MapLight Therapeutics...announced completion of a Phase 1 clinical trial evaluating the bioavailability, safety, and tolerability of an extended release formulation of ML-007, a novel M1/M4 preferring muscarinic agonist, alone and when co-administered with a precision-matched muscarinic antagonist designed to offset peripheral effects....Extended-release ML-007 was well tolerated in this trial at all doses, including those planned for use in the company's upcoming Phase 2 clinical trials for the treatment of schizophrenia and Alzheimer's disease psychosis. Plasma exposures at or above anticipated clinically relevant levels were maintained over the duration of the intended dosing interval....Findings from this study will enable formulation optimization of ML-007C-MA, the fixed-dose combination of ML-007 and its matched muscarinic antagonist, allowing the company to move ML-007C-MA into Phase 2 clinical trials later this year."

New P2 trial • P1 data • Alzheimer's Disease • CNS Disorders • Schizophrenia