KRTX - Karuna/ Zai Lab succeed in late-stage trial for schizophrenia candidate

2023-03-20 07:17:23 ET

Karuna Therapeutics ( NASDAQ: KRTX ) announced Monday that its lead asset KarXT co-developed with Zai Lab Limited ( NASDAQ: ZLAB ), reached the primary endpoint in a Phase 3 trial for adult patients with schizophrenia.

The EMERGENT-3 trial conducted in the U.S. and Ukraine involved 256 adults with a confirmed diagnosis of schizophrenia who received either a flexible dose of KarXT or a placebo two times a day for five weeks.

According to its topline data, KarXT led to a statistically significant and clinically meaningful decline compared to placebo in the Positive and Negative Syndrome Scale (PANSS) total score, a scale to measure schizophrenia symptom severity.

Specifically, the PANSS score for KarXT and placebo groups stood at -20.6 and -12.2, respectively, (p<0.0001) at Week 05.

The discontinuation rates were found to be 37% and 29%, while the treatment-emergent adverse event (TEAE) rates hit 70% and 50% in KarXT and placebo arms, respectively. Discontinuation rates related to TEAEs stood at 6% in the KarXT arm vs. 5% among placebo recipients.

Karuna ( KRTX ) intends to use results from EMERGENT-3 as well as two other placebo-controlled registrational trials called EMERGENT-1, and EMERGENT-2, in a U.S. marketing application for KarXT in mid-2023, expecting a market launch in H2 2024.

The NDA will also include long-term safety data from the ongoing EMERGENT-4 and EMERGENT-5 trials.

KarXT, also known as xanomeline-trospium, is also expected to undergo a bridging study for schizophrenia in China in mid-2023.

Read: Seeking Alpha contributor Peter Way issued a Buy rating on Karuna ( KRTX ) last month, arguing that the psychiatric and neurological conditions the company targets “are receiving increased investing attention” in a post-pandemic world.

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