– RAPID and completed NODE-301 studies could potentially fulfill efficacy requirement for future NDA for etripamil in patients with PSVT –
– RAPID investigates efficacy of second dose of etripamil for patients with persistent PSVT –
– RAPID results expected late 2021/early 2022 –
MONTREAL and CHARLOTTE, N.C., Nov. 18, 2020 /CNW/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that the first patient has been enrolled in RAPID, a pivotal Phase 3 trial of etripamil nasal spray. Etripamil is a novel, short-acting calcium channel blocker in development for the treatment of patients with paroxysmal supraventricular tachycardia (PSVT).
"Commencement of RAPID marks an important milestone for the PSVT etripamil program," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We remain very encouraged by physicians' reactions to the safety and efficacy results from the NODE-301 trial and believe the RAPID trial has the potential to demonstrate increased efficacy and improved overall clinical utility of etripamil. We appreciate and thank the clinical investigators, trial coordinators, etripamil trial team, and patients for their contributions and continued support of RAPID."
The RAPID trial is expected to randomize up to 500 patients and will be completed after a total of 180 confirmed supraventricular tachycardia (SVT) events are reached. Patients in the RAPID trial will be randomized 1:1 to etripamil or placebo. To maximize the potential treatment effect of etripamil, patients who do not experience symptom relief within 10 minutes of the first study drug administration will be directed to administer a second dose of study drug.
As previously announced, the primary efficacy endpoint for both the RAPID and NODE-301 trials 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. Milestone expects to report data from the RAPID trial in late 2021/early 2022.