17.11.2023 08:33:51
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Karuna Announces Positive Results From Phase 1b BP Monitoring Trial Of KarXT In Schizophrenia
(RTTNews) - PureTech Health plc (PRTC, PRTC.L) noted that its Founded Entity, Karuna Therapeutics (KRTX), announced positive results from its Phase 1b open-label, eight-week inpatient trial evaluating the effect of KarXT or xanomeline-trospium on 24-hour ambulatory blood pressure in adults with schizophrenia demonstrating that KarXT was not associated with increases in 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 primary endpoint in the trial.
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.
According to Karuna, 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.
In addition, KarXT was generally well tolerated, with a side effect profile consistent with prior trials in the EMERGENT program.
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