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Monday, December 19, 2022

Cerevel's Emraclidine Does Not Induce High Blood Pressure In Schizophrenia

 

  • Cerevel Therapeutics Holdings, Inc.  announced results from the Phase 1 trial studying the effect of emraclidine on 24-hour ambulatory blood pressure over eight weeks in schizophrenia patients. 
  • The trial's objective was to accurately characterize any potential blood pressure effect for both doses of emraclidine studied (10 and 30 mg QD).
  • On the primary endpoint, emraclidine demonstrated a mean change from baseline at week eight in 24-hour ambulatory systolic blood pressure (SBP) of -2.7 mmHg for the 10 mg QD group and -0.4 mmHg for the 30 mg QD group. 
  • The upper bound was -0.3 mmHg for the 10 mg QD group and 2.1 mmHg for the 30 mg QD group. 
  • As a result, the trial ruled out an increase in blood pressure for both doses.
  • The trial's secondary endpoints demonstrated findings consistent with the primary endpoint, corroborating the overall trial results. 
  • Emraclidine was generally well-tolerated in this trial, with a side effect profile consistent with prior trials.
  • This ambulatory blood pressure monitoring trial was designed in line with FDA guidance.

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