MapLight initiates phase 2 ZEPHYR study of ML-007C-MA to treat schizophrenia

Overview

MapLight Therapeutics, a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating CNS disorders, 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 programme that included 270 healthy volunteers.

From Christopher Kroeger: CEO, MapLight

There is a significant need for new and innovative medicines for the treatment of schizophrenia, a disorder that impacts over 20 million people worldwide,” said Christopher Kroeger, M.D., M.B.A., chief executive officer and founder of MapLight. “We are encouraged by the potential of muscarinic agonists to address the full spectrum of schizophrenia symptoms and remain committed to advancing ML-007C-MA to help meet the urgent needs of these patients.”

Phase 2 ZEPHYR study

• 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.

Statement from Erin Foff: CMO, MapLight

We are encouraged by the differentiated profile demonstrated by ML-007C-MA in phase 1 studies, which included favourable safety and tolerability results with once- and twice-daily dosing, minimal titration requirements and no need for fasting, while achieving CSF exposures expected to be clinically relevant,” said Erin Foff, M.D., Ph.D., chief medical officer of MapLight. “This phase 2 study is designed to be adequately sized and well controlled to evaluate the efficacy, safety and tolerability profile at the doses selected.”

The drug: ML-007C-MA

ML-007C-MA, also referred to as ML-007C/PAC, is an oral, extended-release, fixed-dose combination of the investigational M1/M4 muscarinic agonist, ML-007, co-formulated with a peripherally acting anticholinergic (PAC). Potential differentiation for ML-007C-MA is driven by an optimized pharmacokinetic synchronization of its agonist and antagonist components in the periphery, without sacrificing strong activation of both M1 and M4 receptors in the central nervous system.

About the disorder: Schizophrenia

• Schizophrenia is a complex psychiatric disorder characterized by a range of symptoms that include positive symptoms of hallucinations, delusions, and disorganized thinking; negative symptoms of social withdrawal, decreased emotional expression, anhedonia, and apathy; and cognitive impairment, all of which are major drivers of disability due to significant impairment of social and occupational functioning. 
• Schizophrenia is widely recognized as a chronic and debilitating condition, affecting approximately 3 million people in the US and 20 million globally. 
• Schizophrenia remains one of the leading causes of disability and is associated with an increased risk for premature mortality.

About the company: MapLight Therapeutics

• MapLight Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders. 
• The company was founded by globally recognized leaders in psychiatry and neuroscience research to address the lack of circuit-specific pharmacotherapies available for patients.

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