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Milestone Pharmaceuticals Reports First Quarter 2020 Financial Results and Provides Clinical and Corporate Update
MONTREAL and CHARLOTTE, N.C., May 14, 2020 /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., May 14, 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 first quarter ended March 31, 2020 and provided a clinical and corporate update.\n\"While the NODE-301 trial of etripamil for patients with paroxysmal supraventricular tachycardia (PSVT) did not meet its primary endpoint over the five hour observation period, we are encouraged by the topline data from the trial. With a favorable safety and tolerability profile as well as efficacy signals observed across earlier time points, topline results from NODE-301 reinforce our belief that etripamil has the potential to serve as the first self-administered therapy for the rapid termination of supraventricular tachycardia (SVT) episodes in the at-home setting,\" said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. \"We look forward to working with regulators to determine next steps, with the goal of ensuring that etripamil is able to realize its full potential in patients with PSVT. In parallel, we continue to execute on the balance of the NODE program, including NODE-301B as well as open-label safety studies NODE-302 and NODE-303.\"\nRecent Updates\nReported Topline Results from Phase 3 NODE-301 Trial, Anticipates Regulatory Update in Early 3Q 2020. In March 2020, Milestone reported 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 PSVT. 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, the study did not achieve its primary endpoint of time to conversion of SVT to sinus rhythm compared to placebo over the five hour period following study drug administration (p=0.12). The small number of placebo patients and prolonged efficacy measurement period was found to have confounded the results. The study did demonstrate statistically significant improvements in favor of etripamil over placebo in the important secondary...