- 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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