ML-007 was safe and well tolerated alone at all doses, including those that resulted in and exceeded anticipated clinically relevant exposures. When paired with the muscarinic antagonist, plasma ML-007 concentrations twelve times the minimum plasma target concentration were well tolerated, and an intolerable dose was not identified. No severe or serious adverse events were observed in the study. Importantly, multi-dose tolerability was comparable in elderly and healthy adult cohorts across all explored doses, as assessed by spectrum, severity, and duration of adverse events.

Pharmacokinetic data obtained in this study support twice daily dosing across age groups. The study results also confirmed that ML-007 is highly permeable, bioavailable, and that exposures of ML-007 increase proportionally with increases in dose. MapLight plans to advance a fixed-dose, extended-release combination of ML-007 and muscarinic antagonist into Phase 2 studies next year, with twice-daily dosing across age groups in those studies.

"Currently available treatments do not adequately address the needs of people experiencing psychosis or dyskinesias related to drug treatment. These medications can have intolerable side effects and lead to significant safety concerns for some patient populations, particularly older patients," said MapLight's Chief Medical Officer, Erin Foff, M.D., Ph.D. "This study generated crucial data to help inform further development of ML-007 as a novel option for patients with these conditions. We are extremely encouraged by the safety profile observed in both younger and older subjects."

"These results indicate ML-007 can target M₁ and M₄ receptors with an attractive safety, tolerability, and PK profile. We believe ML-007 has the potential to demonstrate efficacy across multiple indications, and we are considering the broad utility of ML-007 as we build out our Phase 2 development plan," stated Christopher Kroeger, M.D., MBA, Chief Executive Officer, and Founder.

About ML-007

ML-007 is a muscarinic receptor agonist designed to target M₁ and M₄ muscarinic receptor subtypes with no direct activity on dopamine receptors. Deficits in M₁ receptors are linked to schizophrenia, and M₁ receptors directly regulate neural circuits known to be important in both psychosis and cognition. M₄ receptors regulate a complementary neural circuit known to be important in psychosis.

About Schizophrenia 

Schizophrenia is a serious, debilitating mental illness characterized by disturbances in perception, thinking, emotional reaction, and behavior. Schizophrenia can cause people to interpret reality abnormally and includes a combination of positive, negative, and cognitive symptoms. Approximately 60% of people with schizophrenia have no response or only a partial response to the available standard of care treatments, leaving a substantial portion of the population with urgent unmet need.

About Dyskinesias 

Dyskinesias are a category of movement disorders that are characterized by uncontrollable, abnormal, and repetitive muscle movements that can be disruptive to function and quality of life. Dyskinesia can be the result of an underlying condition or develop as a side effect of dopaminergic medications (drug-induced dyskinesia), commonly used to treat Parkinson's disease, depression, bipolar disorder, schizophrenia, and irritability in autism.

About Alzheimer's Disease Psychosis

Over 40% of people with Alzheimer's disease (AD) will experience delusions and hallucinations as part of the disease, a condition known as AD psychosis. The condition is often recurrent, severe, and is associated with an increased likelihood of nursing home placement and increased morbidity and mortality. There is no FDA approved medication for the treatment of AD psychosis.

About MapLight Therapeutics

MapLight Therapeutics is working to develop targeted, novel therapeutics to improve the lives of people with difficult-to-treat brain disorders. The company's unique discovery platform combines novel, proprietary technologies to uncover the individual circuits that misfire in brain disorders and target those circuits with effective, safe therapeutics. MapLight was founded in 2019 by a team of renowned neuroscientists who led the discovery of such groundbreaking technologies as optogenetics and STARmap. Learn more at www.maplightrx.com.                                                                                                

Media Contact for MapLight Therapeutics

armaine Lykins, 
Chief Commercial Officer, 
clykins@maplightrx.com 

Source: prnewswire.com

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