Zai Lab (ZLAB) said Tuesday that a phase 3 trial evaluating the safety and efficacy of KarXT in patients with schizophrenia in China met its primary endpoint as it demonstrated a statistically significant reduction in Positive and Negative Syndrome Scale total score compared with placebo at week 5.
The trial, which enrolled 202 acutely psychotic hospitalized adults in China, also met all key secondary efficacy endpoints, according to the company.
The results are from the 5-week double-blind segment of the study that will be followed by a 12-week open-label extension, Zai Lab added.
The biopharmaceutical company said it is planning to submit a new drug application for approval in China in early 2025.
Shares of the company were down 2.8% in recent trading.
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