After the recent FDA approval for the promising schizophrenia drug Cobenfy (xanomeline and trospium chloride), Bristol Myers Squibb and its partners are moving fast to expand the global reach of the novel antipsychotic.
In a phase 3 bridging study in China, the drug helped patients chart a 9.2-point total-score reduction on the Positive and Negative Syndrome Scale (PANSS) versus placebo at Week 5, BMS’ partner Zai Lab said in a Tuesday release. The result achieved statistical significance.
PANSS is a 30-point rating scale used to measure symptom severity in patients with schizophrenia. Patients on the drug, also known as KarXT, achieved a 16.9-point reduction on the scale, Zai Lab said. The improvement for those on placebo came to 7.7 points.
Zai Lab’s phase 3 trial looked at 202 acutely psychotic hospitalized adults with schizophrenia in China. The study was broken up into two parts: a five-week double-blind period followed by a 12-week open-label extension phase.
The results shared Tuesday come from the study’s initial five-week segment. The company says it plans to unveil full data from the trial at a future medical meeting.
With a positive readout in hand, Zai Lab says it's “moving swiftly” to file an approval application for KarXT in China by early 2025.
The trial win and regulatory blueprint come about a month after KarXT won a landmark approval in the U.S. The drug is designed to target both the positive symptoms of schizophrenia like hallucinations and delusions as well as the negative, which include reduced emotional output, speech, motivation and pleasure.
BMS got its hands on KarXT through its $14 billion buyout of Karuna Therapeutics last December.
According to analysts at William Blair, Cobenfy in the U.S. could achieve sales of roughly $2 billion in 2030. That projection only considers KarXT’s schizophrenia use, with other indications holding the potential to boost the antipsychotic’s peak sales to a range of roughly $3 billion to $5 billion, the analyst team said last month.
Over in China, KarXT could help improve treatment options for the more than 8 million people in the country living with schizophrenia, Zai Lab’s head of global R&D, Rafael Amado, M.D., said in a statement. Fewer than half of schizophrenia patients in China currently receive treatment, while many who are treated fail to receive adequate symptom relief or struggle with debilitating side effects, Amado added.