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Milestone Pharmaceuticals Reports Fourth Quarter and Year-end 2019 Financial Results and Provides Clinical and Corporate Update
– Topline data from Phase 3 NODE-301 trial of etripamil in patients with PSVT expected this month – MONTREAL and CHARLOTTE, N.C., March 6, 2020 /PRNewswire/
About this update from Milestone Pharmaceuticals Inc.
[{"type":"text","content":"– Topline data from Phase 3 NODE-301 trial of etripamil in patients with PSVT expected this month – \n MONTREAL and CHARLOTTE, N.C., March 6, 2020 /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, 2019 and provided a clinical and corporate update.\n\"Our team is keenly focused on delivering the near-term topline readout of the pivotal Phase 3 efficacy and safety trial, NODE-301,\" said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. \"Results from NODE-301, if favorable, have the potential to serve as the sole efficacy registration trial required for an NDA submission with the United States (U.S.) Food and Drug Administration (FDA), bringing us one step closer to providing paroxysmal supraventricular tachycardia (PSVT) patients with a much-needed novel therapeutic option. Supported by compelling results from the Phase 2 NODE-1 trial, we believe etripamil has the potential to alter the PSVT treatment paradigm as the first self-administered therapy for the rapid termination of supraventricular tachycardia (SVT) episodes wherever and whenever they occur.\"\nMr. Oliveto added, \"As we focus on topline results from NODE-301, we remain diligent in executing on the balance of our Phase 3 program of etripamil for PSVT, including the NODE-302 and NODE-303 safety studies, preparing for the potential commercialization of etripamil, and building out our pipeline beyond PSVT. This includes the expected initiation of our first clinical trial of etripamil in patients with atrial fibrillation and rapid ventricular rate.\"\nRecent Updates\nTopline Data from NODE-301 Trial Expected This Month. Milestone expects to report topline data for the NODE-301 trial this month. The NODE-301 trial is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial of etripamil, the Company's novel short-acting calcium channel blocker, designed to terminate SVT episodes in the at-home setting. The primary endpoint of the NODE-301 trial is time to conversion of PSVT to sinus rhythm after the administration of trial drug, as confirmed by a central independent adjudication committee. A statistically signif...