Karuna Tx rockets on new data for KarXT in schizophrenia

8 August 2022

US clinical-stage biotech firm Karuna Therapeutics (Nasdaq: KRTX) saw its shares leap more than 40% to $197.50 pre-market today, as it announced positive top-line results from its Phase III EMERGENT-2 trial evaluating the efficacy, safety, and tolerability of KarXT (xanomeline-trospium), an oral investigational M1/M4-preferring muscarinic agonist, in adults with schizophrenia.

The trial met its primary endpoint, with KarXT demonstrating a statistically significant and clinically meaningful 9.6-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (p<0.0001) at Week 5 (Cohen’s d effect size of 0.61). Additional highlights include:

KarXT demonstrated an early and sustained statistically-significant reduction of schizophrenia symptoms, as assessed by PANSS total score, starting at Week 2 and maintained such reduction through all timepoints in the trial.
KarXT also met key secondary endpoints in the trial, demonstrating a statistically significant reduction in both positive symptoms (eg, hallucinations or delusions) and negative symptoms (eg, difficulty enjoying life or withdrawal from others) of schizophrenia as measured by PANSS positive, PANSS negative, and PANSS Marder negative subscales.
KarXT was generally well tolerated, with a side effect profile substantially consistent with prior trials of KarXT in schizophrenia. These results demonstrate KarXT is not associated with common problematic side-effects of current therapies, such as weight gain, sedation and movement disorders.

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