Karuna Therapeutics has reported that the Phase III EMERGENT-3 trial of KarXT (xanomeline-trospium) in adult schizophrenia patients met its primary endpoint.
The five-week, double-blind, placebo-controlled inpatient trial has been designed for assessing the company’s lead investigational therapy KarXT’s tolerability, safety, and efficacy against placebo in schizophrenia adult patients in Ukraine and the US.
In the trial, a total of 256 adult patients aged between 18 and 65 years, with confirmed schizophrenia diagnosis and with symptoms of psychosis during enrolment, were enrolled.
According to the findings, KarXT showed 8.4-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at week five.
It also showed early and sustained statistically significant symptoms reduction from week two through to the end of the trial, consistent with previous trials.
KarXT was also found to be well tolerated and had a side effect profile that was substantially consistent with previous trials.
The company plans to submit a New Drug Application (NDA) for KarXT to the US Food and Drug Administration (FDA) in the middle of this year.
The submission will include will data from the EMERGENT-1, EMERGENT-2, and EMERGENT-3 placebo-controlled registrational trials along with long-term safety data from the ongoing EMERGENT-4 and EMERGENT-5 trials.
If approved, the potential launch of KarXT is scheduled in the second half of next year.
Karuna Therapeutics president and CEO Bill Meury said: “KarXT has now demonstrated a robust and consistent reduction of symptoms across all three registrational trials, providing a compelling picture of the potential of KarXT in schizophrenia.
“With these data, we are one step closer to a potential treatment option that could provide the first new mechanism of action to treat schizophrenia in several decades.
“We look forward to working closely with the FDA as we focus our attention on the regulatory process, including our upcoming pre-NDA meeting in early second quarter, and remain on track for an NDA submission in mid-2023.”