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Karuna Therapeutics is set to withdraw its previous guidance for reporting topline results from its ongoing Phase III EMERGENT-3 clinical trial of KarXT (xanomeline-trospium) to treat schizophrenia.
The latest development comes after considering the Russia-Ukraine crisis, Karuna said in an SEC filing.
A five-week inpatient trial, EMERGENT-3 is analysing the safety and efficacy of KarXT versus placebo by enrolling 246 adult schizophrenia patients in the US and Ukraine.
An oral investigational antipsychotic, KarXT possesses a new mechanism of action mediated through muscarinic cholinergic receptors.
In a statement, Karuna said: “At this time, the escalating conflict in Ukraine has created uncertainty around the company’s ability to project the timing of topline data from this trial.
“The company is actively monitoring the evolving geopolitical situation between Ukraine and Russia and the impact on clinical trial sites and operations.”
Currently, the enrolment and treatment of participants in the EMERGENT clinical programme at US study centres are underway.
Karuna added that it will provide necessary updates on the sites and operations in Ukraine.
Furthermore, the company plans to update the guidance on the EMERGENT-3 trial on analysing the impact of the Russia-Ukraine crisis on the ongoing trial.
Apart from the EMERGENT-3 trial, KarXT is being analysed in various late-stage studies to treat schizophrenia and Alzheimer’s disease-associated psychosis.
Meanwhile, Karuna recorded a net loss of $143.8m for the full year (FY) 2021 as against $68.6m for FY 2020.
Furthermore, for the fourth quarter (Q4) of 2021, the company reported a net loss of $28m versus $24m for the prior-year period.
The rise in net loss for 2021 was chiefly due to increased operating expenses of $180.8m.
It was driven by research and development expenses linked to the enrolment in the Phase III EMERGENT trials, commencement and enrolment in Phase III ARISE trial, activities supporting new drug application (NDA).
The increase in the number of employees in the company and stock-based compensation expense also contributed to the surge.
