Karuna Therapeutics Inc (NASDAQ:KRTX) released results from its Phase 1b open-label, eight-week inpatient trial evaluating the effect of KarXT (xanomeline-trospium) on 24-hour ambulatory blood pressure in .
The data demonstrated that KarXT was not associated with increases in blood pressure.
The primary endpoint in the trial was the change from baseline at week 8 in 24-hour average ambulatory systolic blood pressure.
In the trial, KarXT demonstrated a mean change from baseline to week 8 in 24-hour ambulatory systolic blood pressure of -0.59 mmHg.
The upper bound of the two-sided 95% confidence interval for the mean change from baseline to week 8 was 1.60 mmHg, thus ruling out a clinically meaningful increase in blood pressure.
Daytime and nighttime systolic blood pressure measurements showed no meaningful change and were generally consistent with the 24-hour average.
Additional vital sign measures collected in the trial, including 24-hour average diastolic blood pressure and heart rate, were consistent with prior trials of KarXT in schizophrenia.
Further, KarXT was generally well tolerated, with a side effect profile consistent with prior trials in the EMERGENT program.
"These results provide a more definitive characterization of the cardiovascular safety profile of KarXT, which substantiates the existing clinical data to date and will supplement our NDA as part of the Day 120 safety update, along with additional safety data, pending filing acceptance," said Steve Brannan, chief medical officer.
Price Action: KRTX shares are up 6.58% at $179.40 on the last check Friday.
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