China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced encouraging topline results from its Phase III multi-center trial evaluating the safety and efficacy of KarXT (xanomeline and trospium chloride) within China. In line with prior global studies, this registrational bridging trial successfully met its primary endpoint, showing a statistically significant reduction in the Positive and Negative Syndrome Scale (PANSS) total score by 9.2 points compared to placebo at Week 5 (-16.9 for KarXT versus -7.7 for placebo, p=0.0014).
The study also achieved all key secondary efficacy endpoints, demonstrating substantial improvements in PANSS positive and negative symptom subscale scores, the PANSS negative Marder factor score, the Clinical Global Impression-Severity (CGI-S) scale at Week 5, and the percentage of PANSS responders at Week 5 when compared to placebo. These key secondary endpoints were rigorously assessed in a predefined sequential order.
KarXT represents a combination therapy that includes an oral M1/M4-preferring muscarinic acetylcholine receptor agonist and a muscarinic acetylcholine receptor antagonist. This innovative formulation aims to address psychiatric conditions such as schizophrenia and Alzheimer’s-related psychosis. Notably, xanomeline preferentially activates muscarinic receptors in the central nervous system, which play a critical role in these disorders, differing from traditional antipsychotics that primarily target dopamine or serotonin receptors. Zai Lab holds an exclusive license from Karuna Therapeutics, Inc.—a company subsequently acquired by Bristol Myers Squibb—to develop, manufacture, and commercialize KarXT across Greater China, including mainland China, Hong Kong, Macau, and Taiwan.- Flcube.com
