Karuna Therapeutics Says It One Step Closer To Potential Treatment Option After Encouraging Schizophrenia Data

Karuna Therapeutics Inc KRTX announced topline results from its Phase 3 EMERGENT-3 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT (xanomeline-trospium) in adults with schizophrenia.
The trial met its primary endpoint. KarXT demonstrated a statistically significant and clinically meaningful 8.4-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo (-20.6 KarXT vs. -12.2 placebo).
Also Read: Analyst Views Karuna Therapeutics' New Licensing Deal 'As Intriguing'.
Consistent with prior trials, KarXT demonstrated an early and sustained statistically significant reduction of symptoms from Week 2 through the end of the trial as assessed by PANSS total score.
KarXT also demonstrated reductions in positive and negative symptoms of schizophrenia as measured by PANSS positive, PANSS negative, and PANSS negative Marder factor subscales – secondary endpoints in the trial.
KarXT demonstrated a clinically meaningful and statistically significant 3.5-point reduction in PANSS positive subscale compared to placebo at Week 5 (-7.1 KarXT vs. -3.6).
While not meeting the threshold for statistical significance at Week 5, KarXT did demonstrate a statistically significant reduction in PANSS negative subscale and PANSS negative Marder factor subscale compared to the placebo at Week 4.
KarXT was generally well tolerated.
The FDA marketing application in schizophrenia will incorporate the efficacy and safety data from the three registrational trials and long-term safety data from the ongoing EMERGENT-4 and EMERGENT-5 trials.
The Company is on track to submit an FDA marketing application in mid-2023, with a potential launch in 2H of 2024 if approved.
Price Action: KRTX shares are down 5.86% at $180.84 on the last check Monday.

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Karuna Therapeutics Says It One Step Closer To Potential Treatment Option After Encouraging Schizophrenia Data