Milestone Pharmaceuticals (NASDAQ:MIST), a company focused on cardiovascular medicines, announced Monday that its lead asset, etripamil reached the primary endpoint in a Phase 3 trial for patients with the heart condition paroxysmal supraventricular tachycardia (PSVT). MIST shares added ~31% pre-market in reaction.
About 2M Americans suffer from PSVT, a cardiovascular condition characterized by brief periods of rapid heartbeat.
Disclosing the topline data, MIST said that the 706-patient global trial named RAPID met the primary endpoint as ~64% of patients who self-administered the calcium channel blocker converted to sinus rhythm within 30 minutes with statistical significance compared to ~31% on placebo.
The company said that RAPID data and data from a previously completed trial called NODE-301 have indicated that those who received etripamil experienced a statistically significant decline in medical interventions and emergency health visits.
The investigational treatment’s safety and tolerability profile was consistent with findings in the previous trials.
MIST has plans to present the full results from the RAPID study at a future medical event and submit the data for publication in a peer-reviewed journal.
Amid ongoing enrollment in the open-label NODE-303 safety trial, MIST intends to submit a marketing application in the U.S. for etripamil in mid-2023, subject to FDA feedback.
MIST is a favorite on Wall Street with five Buy ratings and no Sell or Hold ratings.
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