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Milestone Pharmaceuticals Announces Topline Results from First-of-its-kind Phase 3 NODE-301 Trial of Etripamil for At-home Acute PSVT Treatment
– Study missed primary endpoint of mean time to conversion of SVT to SR over a five-hour period following dosing (p=0.12) – – Etripamil showed rapid
About this update from Milestone Pharmaceuticals Inc.
[{"type":"text","content":"– Study missed primary endpoint of mean time to conversion of SVT to SR over a five-hour period following dosing (p=0.12) –\n– Etripamil showed rapid conversion of SVT to SR during the first 45 minutes (p=0.02), consistent with its known pharmacology –\n– Study demonstrated a positive safety profile showing etripamil was well tolerated in the at-home setting –\n– Small number of placebo patients and prolonged efficacy measurement period confounded results –\n– Company plans to discuss next steps with regulators and continue its full PSVT clinical program, including NODE-301B, NODE-302 and NODE-303 –\n– Company to host conference call today at 5:00 p.m. ET –\n MONTREAL and CHARLOTTE, N.C., March 23, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced topline results from its Phase 3, multicenter, randomized, double-blind, placebo-controlled NODE-301 trial of its investigational new drug, etripamil nasal spray, the Company's novel short-acting calcium channel blocker, in patients with paroxysmal supraventricular tachycardia (PSVT). \n\n \n \n \n \n \n \n\n \nThe NODE-301 trial, which enrolled a total of 431 patients across 65 sites in the U.S. and Canada, is an event-driven Phase 3 efficacy trial of etripamil for terminating supraventricular tachycardia (SVT) episodes in the at-home setting. Etripamil (70mg) did not achieve its primary endpoint of time to conversion of SVT to sinus rhythm (SR) compared to placebo over the five hour period following study drug administration (median time to conversion of 25 minutes [95% CI: 16, 43] for etripamil vs. 50 minutes [95% CI: 31,101] for placebo, p=0.12). Despite early activity, including the conversion of 61% of etripamil patients vs. 45% of placebo patients by 45 minutes (p=0.02), a time period consistent with etripamil's known pharmacological activity, results from the latter part of the analysis confounded the statistical analysis of the primary endpoint.\nThe study demonstrated statistically significant improvements in favor of etripamil over placebo in the important secondary endpoint of patient reported treatment satisfaction, as measured by a treatment satisfaction questionnaire for medication (TSQM-9), including global satisfaction (...