Milestone Pharmaceuticals Announces Presentation of Heart Rate Analysis of NODE-301 Trial of Etripamil in Patients with PSVT
- 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.,
"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
"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
The NODE-301 trial, which enrolled a total of 431 patients across 65 sites in the
A copy of the presentation is available in the Publications section of
NODE-301 is a Phase 3, multicenter, randomized (2:1), double-blind, placebo-controlled, single-administration study of etripamil nasal spray in patients with PSVT. The study targeted a total of 150 adjudicated SVT events. Top line results were reported in March 2020. Despite early activity at 30 minutes, a time period consistent with the relevant pharmacodynamic effect of etripamil, the study did not achieve its primary endpoint of time to conversion of SVT to sinus rhythm (SR) compared to placebo over the pre-specified five-hour period following study drug administration (p=0.12). The small number of placebo patients and prolonged efficacy measurement period was found to have confounded the statistical analysis of the results. The study did demonstrate statistically significant improvements in favor of etripamil over placebo in the important secondary endpoint of patient-reported treatment satisfaction, as well as a trend toward a reduction in emergency department visits. The Company believes the safety and tolerability data from the NODE-301 study is supportive of use of etripamil in a medically-unsupervised setting, with adverse events consistent with those observed in prior trials.
The primary endpoint of the NODE-301 study is time to conversion of an SVT episode to sinus rhythm after the administration of study drug, as confirmed by a central, independent adjudication committee. Secondary study endpoints include relief of symptoms commonly associated with an episode of SVT such as heart palpitations, chest pain, anxiety, shortness of breath, dizziness, or fainting, and rating of treatment satisfaction questionnaire for medication (TSQM).
About Paroxysmal Supraventricular Tachycardia
Paroxysmal supraventricular tachycardia (PSVT) is a condition characterized by intermittent episodes of rapid heartbeat that starts and stops suddenly and without warning that affects approximately two million Americans. Episodes of SVT are often associated with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain medications, including adenosine, beta-blockers or calcium channel blockers, have long been used for the acute treatment of PSVT. However, these medications must be administered intravenously and under medical supervision, usually in an emergency department or other acute care setting.
About Atrial Fibrillation with Rapid Ventricular Rate
Atrial fibrillation (AFib) is a common arrhythmia marked by an irregular and often rapid heartbeat. AFib is estimated to affect five million patients in the
Etripamil, Milestone's lead investigational product, is a novel calcium channel blocker designed to be a rapid-response therapy for episodic cardiovascular conditions. As a nasal spray that is self-administered by the patient, etripamil has the potential to shift the current treatment experience for many patients from the emergency department to a medically-unsupervised setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials ongoing in paroxysmal supraventricular tachycardia (PSVT) and now with a Phase 2 proof-of-concept trial underway in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR).
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "may," "will," "expect," "continue," "estimate," "potential," "progress" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential of etripamil as a promising therapy for PSVT patients, the design, progress, timing, scope and results of the RAPID and ReVeRA trials, Milestone's ability to execute on the remainder of the PSVT program, Milestone's ongoing plans to study etripamil in atrial fibrillation patients and estimates about the addressable market and commercial potential for treatments of atrial fibrillation with rapid ventricular rate. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, the risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain regulatory approval process, uncertainties related to the timing of initiation, enrollment, completion and evaluation of clinical trials, and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, as well as risks related to pandemics and public health emergencies, including those related to the ongoing COVID-19 pandemic, and risks related the sufficiency of Milestone's capital resources and its ability to raise additional capital. These and other risks are set forth in Milestone's filings with the
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