- Etripamil significantly decreased heart rate during SVT episodes and independent of conversion to SR –
- HR changes occurred within 5 minutes and were sustained for 60 minutes –
- Data presented at AHA Scientific Sessions 2021 -
MONTREAL and CHARLOTTE, N.C., Nov. 15, 2021 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced new data from a post-hoc analysis of the Phase 3, randomized, double-blind, placebo-controlled NODE-301 trial of etripamil nasal spray, the Company's novel investigational, short-acting calcium channel blocker, in patients with paroxysmal supraventricular tachycardia (PSVT). The analysis demonstrated that etripamil significantly decreased heart rate (HR) prior to conversion to sinus rhythm (SR). The data were featured in a poster presentation titled, "Etripamil Nasal Spray Reduces Heart Rate in Patients with Paroxysmal Supraventricular Tachycardia Prior to Conversion to Sinus Rhythm," at the American Heart Association (AHA) Scientific Sessions 2021 held November 13-15, 2021.
"Data reported in this analysis align with the potential of etripamil to serve as an effective treatment option for patients with PSVT in the medically-unsupervised setting," said James Ip, M.D., Associate Professor of Clinical Medicine, Division of Cardiology, Weill Cornell Medicine, New York Presbyterian Hospital. "Beyond PSVT, these findings provide a strong impetus for the continued assessment of etripamil in other conditions requiring ventricular rate reduction, such as atrial fibrillation with rapid ventricular response (AFib-RVR)."
"I would like to congratulate the study authors and thank our team, the study investigators, and the clinical site colleagues for their hard work in making this analysis possible, and would also like to extend a special thank you to the patients for supporting the etripamil development initiative," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We remain on track to report topline data from the RAPID trial in the second half of 2022, and in parallel, continue to advance the entire etripamil development program. We are committed to elucidating the full potential of etripamil to treat symptomatic episodes of elevated HR associated with these conditions in the at-home setting."
The NODE-301 trial, which enrolled a total of 431 patients across 65 sites in the U.S. and Canada, was an event-driven, Phase 3 efficacy trial of etripamil versus placebo for terminating supraventricular tachycardia (SVT) episodes in a medically-unsupervised setting. The analysis assessed the effect of etripamil on HR during the SVT episode and prior to conversion to SR, as well as the correlation of HR with patient-reported outcomes in 150 patients (etripamil, n=102; placebo, n= 48). Patients treated with etripamil experienced a significantly greater reduction in mean HR from baseline within 10 minutes of administration as compared to placebo-treated patients (p