Zai Lab has reported positive outcomes from its Phase III clinical trial of KarXT (xanomeline and trospium chloride) in China to treat schizophrenia.
The registrational bridging trial, which assessed the safety and efficacy of KarXT, involved 202 acutely psychotic hospitalised adult patients with this condition.
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Schizophrenia is a mental disorder that affects over eight million individuals in China, with many lacking adequate treatments.
The Phase III multi-centre, randomised, placebo-controlled trial consisted of a five-week double-blind phase, followed by a 12-week open-label extension.
The primary endpoint was met, with KarXT showing a significant 9.2-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score, compared to a placebo, at week five.
Zai Lab global research and development head and president Rafael Amado said: “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.
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By GlobalData“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.”
Secondary endpoints also showed positive results in various PANSS subscales and the Clinical Global Impression-Severity (CGI-S) scale.
The therapy has been licensed to Zai Lab by Karuna Therapeutics, a company subsequently acquired by Bristol Myers Squibb (BMS).
This licensing agreement covers development, manufacturing, and commercialisation in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
The trial’s improvement is consistent with previous global studies of KarXT. At week five, the medication led to a 1.9-point reduction in the PANSS positive subscale and a 2.5-point decline in the PANSS negative subscale, compared to a placebo. The safety profile of KarXT was in line with prior trials, with no new or unexpected safety signals.
Zai Lab is currently preparing to submit a new drug application (NDA) to China’s National Medical Products Administration (NMPA) for the use of KarXT in treating schizophrenia, targeting an early 2025 submission date.
