Milestone Pharmaceuticals Announces First Patient Enrolled In NODE-303 Open-Label Safety Study Of Etripamil In PSVT

Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a Phase 3 clinical-stage biopharmaceutical company dedicated to developing and commercializing etripamil for the treatment of cardiovascular indications, today announced that the first patient has been enrolled in the Phase 3 NODE-303 study. NODE-303 is the Company’s open-label, global safety study of etripamil, the Company’s novel, potent and short-acting calcium channel blocker, in patients with paroxysmal supraventricular tachycardia (PSVT).

“Commencement of enrollment in NODE-303 marks an important step forward for our Phase 3 program of etripamil in PSVT, where current standards of care are restricted to the burdensome and costly acute care setting,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We believe etripamil has the potential to alter the PSVT treatment paradigm, providing patients with a self-administered intervention to effectively terminate PSVT episodes wherever and whenever they occur. We remain focused on the execution of the entirety of the program, and continue to expect topline results from NODE-301 in the first half of 2020.”

Milestone’s pivotal Phase 3 program of etripamil in PSVT, which was designed in consultation with U.S. and European Union regulatory authorities, is designed to support potential filings in the U.S. and European Union. It consists of three distinct trials, including one randomized, double-blind, placebo-controlled efficacy trial, NODE-301, its open-label safety extension study, NODE-302, and NODE-303.

NODE-303 is a global study which will primarily evaluate the safety of etripamil when self-administered without medical supervision during single or multiple PSVT episodes. Important secondary measures include efficacy, patient quality of life and pharmacoeconomic assessments. The study represents the largest study ever conducted in PSVT, assessing up to 1,500 patient episodes from patients who did not participate in NODE-301 or NODE-302. As previously announced, the U.S. Food and Drug Administration agreed to allow initiation of patient enrollment in the NODE-303 study in a population consistent with NODE-301 and NODE-302, including older patients and those patients taking concomitant beta-blockers and calcium channel blockers, and without the in-office safety test dose that is currently required in NODE-301. – PR Newswire