Milestone Pharmaceuticals has enrolled the first Canadian participant in its ongoing multinational Phase III clinical trial, ReVeRA-301, which is evaluating etripamil nasal spray to treat atrial fibrillation with rapid ventricular rate (AFib-RVR).
The Montreal Heart Institute became the first site in Canada to join the study, enrolling the initial participant as part of a planned recruitment of approximately 150 patients with treated AFib-RVR events globally.
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ReVeRA-301, the double-blind, randomised, multi-centre, placebo-controlled trial, is assessing a 70mg repeat dose of etripamil nasal spray, a regimen identical to one that received approval from the US Food and Drug Administration (FDA).
The FDA approved this regimen for paroxysmal supraventricular tachycardia (PSVT) under the product name Cardamyst.
Participants self-administer the investigational treatment during symptomatic events in medically unsupervised environments, including at home.
The trial’s primary objective is to evaluate whether etripamil can reduce ventricular rate within 30 minutes following administration. Secondary endpoints include patient-reported improvements in symptoms.
Data collected in this trial are supporting a single-study supplemental new drug application registration pathway in AFib-RVR, utilising safety information from previous studies.
Milestone Pharmaceuticals chief medical officer David Bharucha said: “Activating clinical trial sites and enrolling study participants in Canada are important steps toward advancing ReVeRA-301 and reflect the momentum behind our global enrolment efforts following the recent first enrolled patient in the US.
“We are honoured to continue our work with the strong Canadian community of cardiovascular investigators and centres with deep experience in atrial fibrillation research.”
The ReVeRA-301 study builds on evidence from ReVeRA-201, a preceding Phase II trial that assessed the use of etripamil nasal spray for acute symptom improvement in emergency room settings for AFib-RVR patients.
That earlier study found single 70mg doses were linked to decreases in ventricular rate and increased patient satisfaction.
AFib-RVR episodes frequently require urgent interventions, often managed in emergency departments with treatments such as intravenous beta blockers, calcium channel blockers, or electrical cardioversion.
Cardamyst is authorised in the US for conversion of acute symptomatic PSVT to sinus rhythm in adults, and etripamil continues to be studied in Phase II and Phase III trials for additional indications.
