Neurocrine Biosciences has commenced a Phase III registrational programme to assess investigational oral muscarinic M4 selective orthosteric agonist NBI-1117568 as a treatment for schizophrenia in adult patients.
The double-blind, placebo-controlled trial is assessing the therapy’s safety, tolerability, and efficacy in adults with a primary diagnosis of schizophrenia who are having an acute exacerbation or relapse of symptoms.
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It is anticipating the enrolment of nearly 280 subjects. The primary goal is to measure the decrease in the Positive and Negative Syndrome Scale (PANSS) from baseline, with improvement in the Clinical Global Impression of Severity (CGI-S) scale as a key secondary endpoint.
This commencement of the trial is based on the encouraging top-line data from the Phase II trial, which showed a meaningful reduction in PANSS scores and improvements across several secondary endpoints.
In this trial, the therapy was found to be tolerated well across all the investigated doses, with very few cardiovascular and gastrointestinal adverse events observed.
Neurocrine Biosciences’ chief medical officer Eiry Roberts said: “There is a significant need for new and innovative medicines to treat schizophrenia, a disorder that impacts millions of people and their families.
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By GlobalData“With positive Phase II data in hand, we’re excited to advance this investigational novel compound that works directly and selectively at the muscarinic M4 receptor.”
The company noted that NBI-1117568 presents a potential new mechanism for schizophrenia treatment without requiring combination therapy to reduce side effects related to off-target pharmacology while being independent of acetylcholine presence for efficacy.
Neurocrine’s portfolio also includes other muscarinic agonist assets, such as NBI-1117567, NBI-1117569, and NBI-1117570, for which it acquired the development and commercialisation rights from Nxera Pharma.
Additionally, the company is advancing NBI-1076986, an internally discovered and developed selective M4 antagonist.
Earlier this year, the company initiated a Phase I trial of NBI-1140675, a small-molecule vesicular monoamine transporter 2 (VMAT2) inhibitor, in healthy adults.
