Zai Lab Ltd. (ZLAB) Monday announced that its partner Karuna Therapeutics, Inc. (KRTX) reported its Phase 3 EMERGENT-3 trial met its primary endpoint for its lead investigational therapy KarXT in adults with schizophrenia. Karuna is planning to submit an NDA to the FDA in mid-2023.
The trial evaluated the efficacy, safety, and tolerability of KarXT demonstrating a statistically significant and clinically meaningful 8.4-point reduction in Positive and Negative Syndrome Scale total score compared to the placebo at Week 5.
Earlier trials showed an early and sustained statistically significant reduction of symptoms from Week 2.
KarXT was generally well tolerated, with a side effect profile substantially consistent with prior trials of KarXT. The overall discontinuation rate in the trial was 33 percent.
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