Milestone Pharmaceuticals Inc. (MIST), a clinical-stage biopharmaceutical company focused on cardiovascular medicines, announced Monday positive results from Phase 3 RAPID clinical trial of Etripamil nasal spray in patients with Paroxysmal Supraventricular Tachycardia or PSVT.
In pre-market activity on Nasdaq, Milestone shares were gaining around 27.4 percent to trade at $10.82.
The trial met its primary endpoint, with 64.3% of patients self-administering etripamil converting to sinus rhythm within 30 minutes compared to 31.2% on placebo.
The company said it plans to submit a New Drug Application or NDA for etripamil in patients with PSVT to the U.S. Food and Drug Administration in mid-2023.
PSVT is a condition that is characterized by intermittent episodes of a rapid heartbeat that starts and stops suddenly. Episodes of supraventricular tachycardia or SVT are often associated with symptoms such as palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety.
Certain intravenous medications, including adenosine, beta-blockers and calcium channel blockers, have been used for the acute treatment of PSVT, but they must be administered under medical supervision.
Etripamil, a new chemical entity, is the company’s investigational calcium channel blocker designed to be a rapid-response therapy for episodic cardiovascular conditions.
Etripamil as a nasal spray is self-administered by the patient, and it has the potential to shift the current treatment experience from the emergency department to a medically unsupervised setting.
Milestone said it is conducting a comprehensive development program for etripamil, with Phase 3 trials ongoing in PSVT and a Phase 2 proof-of-concept trial that is underway in patients with atrial fibrillation with rapid ventricular rate or AFib-RVR.
Milestone will present full results from the Phase 3 RAPID clinical trial at an upcoming medical meeting and also will submit that to a peer-reviewed journal for publication.
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