The multi-arm, placebo-controlled, multi-stage inpatient trial is designed to assess the safety, tolerability, efficacy, and pharmacokinetics of NBI-1117568.
Being carried out at 15 US centres, the trial will enrol nearly 200 adult subjects.
Various active dose levels of NBI-1117568 will be analysed in the trial.
The variation from baseline in the total Positive and Negative Syndrome Scale (PANSS) score to week six is the trial’s primary outcome measure.
NBI-1117568 is a muscarinic M4 selective acetylcholine receptor agonist.
The company had obtained the rights for developing the compound from Sosei Heptares.
A serious and complex ailment, schizophrenia has heterogeneous symptoms.
Standard therapy approaches for the syndrome depend on the usage of antipsychotic medications linked to metabolic syndrome and neurologic symptoms.
Neurocrine Biosciences chief medical officer Eiry Roberts said: “Initiation of this Phase II study for NBI-1117568 brings forward a first-in-class, orally active, highly selective investigational M4 agonist as a potential treatment for schizophrenia, a serious and complex psychiatric syndrome impacting 0.5-1.0% of the US population and approximately 20 million people worldwide.
“The differentiated profile of NBI-1117568 in terms of its selectivity as an M4 agonist may provide an opportunity for efficacy in treating the symptoms of psychosis, with a potentially different side effect profile.”
In December last year, the company reported that the Phase III KINECT-HD clinical trial of valbenazine met the primary goal of decreasing chorea severity in adult Huntington’s disease patients.