Zai Lab presents data from Phase 3 of KarXT for schizophrenia in China

Zai Lab (ZLAB) announced positive topline results from the company’s Phase 3 multi-center trial evaluating the safety and efficacy of KarXT or xanomeline and trospium chloride, in China. Consistent with previous global studies, the registrational bridging trial met its primary endpoint, with KarXT demonstrating a statistically significant 9.2-point reduction in the Positive and Negative Syndrome Scale or PANSS, total score compared to placebo at Week 5 . The study also met all key secondary efficacy endpoints, demonstrating a significant improvement in PANSS positive symptom subscale score, PANSS negative symptom subscale score, PANSS negative Marder factor score, the Clinical Global Impression-Severity CGI-S scale at week five and percentage of PANSS responders at week five compared to placebo. Key secondary endpoints were formally tested sequentially in a predefined order. “The positive findings we observed in this bridging trial will contribute to a large global dataset for KarXT and demonstrate that this novel compound has the potential to be an important new treatment option for adults with schizophrenia in China,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “More than 8 million people in China live with schizophrenia, and fewer than half receive treatment, while many more do not get adequate symptom relief and suffer debilitating side effects from available antipsychotic therapies. This clinical trial is an example of Zai Lab’s capabilities as a partner that helps to expand access to innovative treatments in collaboration with our global partners.” Based on these results, Zai is moving swiftly to submit New Drug Application NDA to China’s National Medical Products Administration NMPA in early 2025