Milestone Pharmaceuticals Inc（MIST）のニュースとイベントMISTMilestone Pharmaceuticals Inc

Milestone Pharmaceuticals Enrolls First European Patient in ReVeRA-301 Trial

Milestone Pharmaceuticals announced that the first European patient has been enrolled in ReVeRA-301, its ongoing Phase 3 pivotal trial evaluating etripamil nasal spray for the treatment of atrial fibrillation with rapid ventricular rate. The study participant was enrolled at a site within the Dutch Cardiovascular Investigator Network in the Netherlands as enrollment advances toward the study's target of approximately 150 AFib-RVR patients with treated AFib-RVR events. ReVeRA-301 is evaluating the same 70 mg repeat-dose regimen that is FDA-approved for the treatment of paroxysmal supraventricular tachycardia as Cardamyst nasal spray.

Milestone Pharmaceuticals Launches ReVeRA-301 Clinical Trial in Canada

Milestone Pharmaceuticals announced that the Montreal Heart Institute, recently activated as the first Canadian clinical trial site for the ReVeRA-301 Phase 3 trial evaluating etripamil nasal spray for the treatment of atrial fibrillation with rapid ventricular rate, has enrolled their first patient. The expansion into Canada advances the multinational study toward its target of 150 patients with treated AFib-RVR events. ReVeRA-301 is evaluating the same 70 mg repeat-dose regimen that is U.S. Food and Drug Administration-approved for paroxysmal supraventricular tachycardia as CARDAMYST nasal spray.

Milestone Pharmaceuticals Receives Approval for Etripamil Nasal Spray in China

Milestone Pharmaceuticals announced that China's National Medical Products Administration has approved etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia in adults. Etripamil, marketed in the United States as CARDAMYST nasal spray, is a self-administered treatment for adults with PSVT. The NMPA decision marks the first regulatory approval of etripamil outside the United States and triggers a $2M milestone payment to Milestone Pharmaceuticals. Everest Medicines has an exclusive license with Milestone to develop etripamil nasal spray in Greater China. Under the License Agreement with Everest, Milestone is also eligible to receive up to $98M in commercial and development milestones and tiered royalties of up to 18% on future sales of etripamil in Greater China. The NMPA approval was based on data from the global pivotal Phase 3 RAPID study and the Phase 3 JX02002 study conducted in China. JX02002 met its primary endpoint, demonstrating that etripamil was significantly superior to placebo in converting PSVT to sinus rhythm within 30 minutes of treatment. Overall, treatment-emergent adverse events were comparable between the etripamil and placebo groups, and no serious adverse events were reported within 24 hours after dosing across Phase 3 studies.