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Milestone Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Clinical and Corporate Update
- RAPID topline data readout expected mid-second half 2022 MONTREAL and CHARLOTTE, N.C., March 24, 2022 /PRNewswire/ -- Milestone Pharmaceuticals Inc.
About this update from Milestone Pharmaceuticals Inc.
[{"type":"text","content":"- RAPID topline data readout expected mid-second half 2022 \n MONTREAL and CHARLOTTE, N.C., March 24, 2022 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today reported financial results for the fourth quarter and year ended December 31, 2021 and provided a clinical and corporate update.\n\"2021 was a year of focused execution across our ongoing clinical programs which are evaluating etripamil in patients with PSVT and AFib-RVR,\" said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. \"We are well-positioned for a transformative 2022, with topline data from the pivotal Phase 3 RAPID trial on track for the middle of the second half of the year. We are committed to unlocking the full potential of etripamil, if approved, to serve as a meaningful therapeutic option for patients with episodic cardiovascular conditions. We look forward to providing updates on our progress throughout the coming quarters.\"\nRecent Updates\nCompany Expects to Report Topline Data in Mid-Second Half 2022. The RAPID trial, which is targeting a total of 180 confirmed PSVT events, is expected to randomize approximately 500 patients 1:1 to receive either etripamil or placebo. To maximize the potential treatment effect of etripamil, patients will be directed to administer a repeat dose of study drug if they do not experience symptom relief within 10 minutes of the first study drug administration. The primary efficacy analysis for both the RAPID trial and the completed NODE-301 trial will be time to conversion of supraventricular tachycardia (SVT) over the first 30 minutes following initial study drug administration, with a target p-value of less than 0.05 for each trial. The RAPID and NODE-301 trials could potentially serve to fulfill the efficacy requirement for a future New Drug Application (NDA) submission for etripamil in patients with PSVT.New Clinical Analysis Evaluating the Drug Characteristics and Safety of Etripamil to be Presented at the American College of Cardiology (ACC) 71st Annual Scientific Session and Expo. New analyses on the safety, tolerability, pharmacokinetics and pharmacodynamics of etripamil will be presented at the upcoming ACC 71st Annual Scientific Session and Expo tak...