Karuna Therapeutics has reported that KarXT showed promise for the treatment of acute psychosis in schizophrenia patients enrolled in a Phase II clinical trial.
KarXT is a combination of xanomeline and trospium intended to treat psychosis and associated symptoms via the stimulation of muscarinic receptors in the central nervous system (CNS).
Xanomeline is a muscarinic receptor agonist, while trospium is a muscarinic receptor antagonist. This combination is expected to avoid the side effects that are seen with existing antipsychotic standard of care drugs.
The drug candidate met the trial’s primary endpoint, with a statistically significant and clinically meaningful mean decrease of 11.6 points in total Positive and Negative Syndrome Scale (PANSS) score compared to placebo.
The drug also showed a statistically significant decrease on secondary endpoints of PANSS-Positive and PANSS-Negative scores.
KarXT was well tolerated and discontinuation rates were found to be similar between the treatment and placebo arms.
The overall adverse event (AE) rate with KarXT and placebo was 54% and 43%, respectively. The most common AEs were nausea, constipation, dyspepsia, dry mouth and vomiting.
For the Phase II trial, a total of 182 adults aged 18 to 60 with DSM-5 schizophrenia and acute psychosis were recruited.
Karuna Therapeutics CEO, president and chairman Steve Paul said: “The schizophrenia treatment landscape has remained rather stagnant for decades with therapeutic options relying on discoveries dating back to the 1950s.
“KarXT and its novel muscarinic receptor mechanism of action represent the potential to become a true advancement in how schizophrenia is treated, allowing patients relief from their debilitating psychotic symptoms without experiencing some of the very troubling side effects associated with current treatments.”
The company intends to further analyse the Phase II data to gain insights into the potential of the drug candidate in schizophrenia and other CNS disorders, such as psychosis in Alzheimer’s disease and pain.
The company also plans to launch a Phase III study in schizophrenia patients by the end of next year.