Karuna Pharmaceuticals has dosed the first patient in a Phase II study to examine the efficacy and safety of Karuna-Xanomeline-Trospium (KarXT) for treatment of psychosis in schizophrenia.
Around 160 patients are expected to be enrolled in the double-blind, placebo-controlled trial.
In the trial, patients will be randomised in a 1:1 ratio to receive either KarXT or placebo for a period of five weeks.
Patients in the KarXT arm will receive 100mg/20mg xanomeline/trospium, with the option to increase the dose to 125mg/30mg xanomeline/trospium following the trial's first week.
The trial’s primary objective is a total change from baseline Positive and Negative Syndrome Scale (PANSS) score compared to placebo.
Additional objectives include the evaluation of cognitive and negative symptoms in addition to general symptomology.
Top-line data from the trial is expected to be available by the end of next year.
Karuna Pharmaceuticals CEO Steve Paul said: "Our Phase II study uses the same fundamental design as the successful efficacy study conducted previously with xanomeline alone.
"We have designed KarXT as a novel approach to reduce the cholinergic sides effects related to the activation of peripheral muscarinic receptors that were observed in previous studies by Eli Lilly.
"We have now demonstrated the improved tolerability in two Phase I studies, including with the proprietary co-formulation of xanomeline and trospium."
KarXT is Karuna’s lead investigational product for the treatment of psychosis in schizophrenia and features xanomeline.
Xanomeline is a new muscarinic acetylcholine receptor agonist that has demonstrated efficacy in placebo-controlled human trials for schizophrenia and Alzheimer’s, as well as trospium chloride, a muscarinic receptor antagonist.
In a previous Phase I trial, KarXT demonstrated tolerability at dose levels exceeding those shown to be efficacious in earlier studies of xanomeline alone.
The trial included 70 healthy subjects.