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Milestone Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Clinical and Corporate Update
MONTREAL and CHARLOTTE, N.C., March 29, 2021 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the
About this update from Milestone Pharmaceuticals Inc.
[{"type":"text","content":"MONTREAL and CHARLOTTE, N.C., March 29, 2021 /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, 2020 and provided a clinical and corporate update.\n\"We are keenly focused on executing on our etripamil development program for patients with PSVT following clear regulatory guidance in the second half of 2020 and commencement of the pivotal Phase 3 RAPID study,\" said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. \"We believe that etripamil has the potential to overcome the limitations of the current standard of care for PSVT, which is invasive, anxiety-provoking and costly, and to serve as a meaningful new therapeutic option for patients.\"\nMr. Oliveto added, \"Beyond PSVT, we are pleased to announce that the Phase 2 ReVeRA study of etripamil in patients with atrial fibrillation and rapid ventricular rate is now underway. We are committed to assessing the full potential of etripamil and helping patients with episodic cardiovascular conditions, and we look forward to providing updates on our progress in the coming months.\" \nRecent Updates\nCompany Continues to Guide to Topline Data from Pivotal Phase 3 RAPID Trial in Late 2021/Early 2022. The pivotal Phase 3 RAPID trial, which is targeting a total of 180 adjudicated paroxysmal supraventricular tachycardia (PSVT) events, is expected to randomize approximately 500 patients 1:1 to receive either etripamil nasal spray or placebo. As previously announced, patients will be directed to administer a second dose of study drug if they do not experience symptom relief within 10 minutes of the first study drug administration to help maximize the potential treatment effect of etripamil. The primary efficacy analysis for both the RAPID trial and the already-completed NODE-301 trial will be time to conversion of SVT within 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) for etripamil in patients with PSVT.While clinical site initiations and patient enrollme...