Milestone启动etripamil鼻喷剂AFib-RVR适应症关键3期试验

Milestone Pharmaceuticals Inc. (MIST), an emerging commercial-stage biopharmaceutical company focused on cardiovascular medicines, announced the initiation of its pivotal Phase 3 ReVeRA-301 trial evaluating etripamil nasal spray for the self-administered treatment of atrial fibrillation with rapid ventricular rate (AFib-RVR).
The first patient has been enrolled in the multinational, randomized, double-blind, placebo-controlled study, which is designed to evaluate whether etripamil can rapidly reduce ventricular rate and improve symptoms in patients experiencing AFib-RVR outside a medical setting.
Phase 3 ReVeRA-301 Trial
ReVeRA-301 is expected to enroll approximately 150 adults with symptomatic AFib-RVR. Patients will self-administer etripamil in a medically unsupervised setting, such as at home, using the same 70 mg repeat-dose regimen that is currently FDA-approved for etripamil in paroxysmal supraventricular tachycardia (PSVT).
The primary endpoint is reduction in ventricular rate within 30 minutes, while a key secondary endpoint will assess symptom improvement through patient-reported outcomes.
Milestone said it is pursuing a single-study supplemental New Drug Application (sNDA) registration pathway for etripamil in AFib-RVR based on the safety data generated to date.
Clinical Data Supporting Development
The Phase 3 program builds on findings from the Phase 2 ReVeRA-201 study, which evaluated etripamil nasal spray in patients with symptomatic AFib-RVR in an emergency room setting.
In the Phase 2 study, a single 70 mg dose of etripamil reduced ventricular rate and improved both symptom relief and treatment satisfaction.
The company is now evaluating whether these findings can be replicated when patients self-administer the treatment during an AFib-RVR episode without immediate medical supervision.
Potential To Reduce Emergency Care Burden
AFib-RVR episodes can cause palpitations, shortness of breath and weakness and frequently require urgent medical evaluation.
Current acute treatment options commonly involve emergency department care and intravenous medications or electrical cardioversion.
Milestone believes a rapid, self-administered nasal therapy could provide patients with an on-demand treatment option while potentially reducing reliance on emergency department visits.
The company said it is activating clinical trial sites across North America and internationally to support enrollment in the event-driven global Phase 3 study.
CARDAMYST Commercial Platform
Etripamil is already approved in the U.S. as CARDAMYST nasal spray for the conversion of acute symptomatic PSVT episodes to sinus rhythm in adults.
CARDAMYST is a calcium channel blocker designed as a rapid-response, self-administered nasal treatment, allowing patients to manage eligible episodes without immediate medical oversight.
Beyond AFib-RVR, etripamil is also being evaluated in Phase 2 development for PSVT in pediatric patients.
Milestone expects the ReVeRA-301 trial to expand the potential application of its commercially approved etripamil platform into AFib-RVR, addressing a significant unmet need in acute cardiovascular care.
MIST has traded between $1.00 and $3.06 over the past year. The stock closed Thursday's trading at $1.03, down 4.63%. In pre-market trading the stock is at $1.06, up 3.68%.
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