KRTX - Karuna Therapeutics jumps 52% as schizophrenia trial meets key goal

The shares of Karuna Therapeutics ( NASDAQ: KRTX ) surged ~52% in the pre-market on Monday after the clinical-stage biotech announced that its late-stage trial for experimental schizophrenia therapy KarXT met the primary endpoint. The ADRs of Chinese biotech Zai Lab Limited ( ZLAB ), Karuna's ( KRTX ) partner for the program also added ~15% in reaction.

The Phase 3 trial named EMERGENT-2 involved 252 adults with schizophrenia in the U.S. who were randomized 1:1 to receive KarXT (n=126) or placebo (n=126) two times a day (BID) for five weeks.

In terms of the Positive and Negative Syndrome Scale (PANSS), KarXT led to a statistically significant and clinically meaningful 9.6-point reduction of the measure, achieving the primary endpoint compared to placebo (-21.2 KarXT vs. -11.6 placebo, p<0.0001) according to topline data.

In addition, the KarXT impact appeared early and sustained with statistical significance, the company said, noting that the reduction of symptoms measured using PANSS total score started at Week 2, and the decline was seen across all time points of the trial.

The experimental therapy was well tolerated on the safety front, and the overall discontinuation rates between KarXT and placebo arms were broadly similar (25% vs. 21%). The incidence of treatment-emergent adverse events stood at 75% and 58%, respectively.

Karuna ( KRTX ) expects to disclose data from the additional analysis of the EMERGENT-2 trial at future medical events.

The EMERGENT program consists of five clinical trials, including three ongoing studies. Topline data from one such trial called EMERGENT-3 is expected in 1Q 2023.

In 2019, the company announced that the EMERGENT-1 study of the program also met the primary endpoint .

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