Milestone Pharmaceuticals Announces Presentation of Data from Phase 3 NODE-302 Study of Etripamil for the Treatment of PSVT
- Patients successfully self-managed PSVT episodes with etripamil which reduced need for ED intervention -
- As in other studies, etripamil was well tolerated by patients -
- Data to be featured during late breaking session at Heart Rhythm 2022 -
MONTREAL and CHARLOTTE, N.C.,
"PSVT is a highly disruptive condition that places a heavy burden on patients because of the unpredictable and sudden onset of symptoms that can require visits to the emergency department (ED) for treatment," said
"These data, which show that 85% of the eligible patients chose to enter the NODE-302 extension study after experiencing etripamil administration in the prior study, are very encouraging as we progress in our mission of helping patients suffering from tachycardias," said
NODE-302 was a single-arm, open-label extension study of the Phase 3, randomized, double-blind, placebo-controlled NODE-301 study. The primary objective of the NODE-302 study was to assess the safety of patients dosing 70 mg of etripamil over multiple episodes. Patients were eligible to participate in NODE-302 if they dosed themselves for a perceived episode of PSVT in NODE-301. In NODE-302, patients self-administered 70 mg of etripamil nasal spray in response to a perceived PSVT episode after a failed attempt at a vagal maneuver and were monitored for five hours using an ambulatory cardiac monitoring system. The study allowed patients to treat up to 11 unique episodes.
Of 198 eligible NODE-301 patients, 169 (85%) enrolled in NODE-302 and 105 (62%) experienced a perceived episode of PSVT, self-administered etripamil, and were included in the safety population. The calculated median (mean) number of treated episodes extrapolated over the course of one year was 3.7 (6.0). Of the 105 patients who treated themselves for a perceived episode, 92 (88%) had a positively adjudicated PSVT episode. There was a total of 188 positively adjudicated PSVT episodes (range 1-10 episodes per patient) over a median of 7.4 months follow-up. Overall, the PSVT conversion rate at 30 minutes following etripamil administration was 60.2%, with a median time to conversion of 15.5 minutes (95% CI, 11.3-22.1 minutes). Among 40 patients who self-treated two consecutive episodes, 21 of 26 (81%) who converted on their first episode were also successfully converted on their second. Moreover, the need for ED intervention to terminate a PSVT episode was low (13% of patients and 8.5% of positively adjudicated PSVT episodes). Etripamil was generally well-tolerated, with adverse events consistent with those observed in previous trials; the majority of adverse events related to treatment were localized to the nasopharynx administration site, and were mild and brief.
A copy of the presentation will be available on the Publications section of the Milestone Pharmaceuticals website.
Paroxysmal supraventricular tachycardia (PSVT) is a condition characterized by intermittent episodes of rapid heartbeat that start and stop suddenly and without warning that
Etripamil, Milestone's lead investigational product, is a 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 PSVT and 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," "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 to serve as a promising therapy for PSVT patients to safely and effectively self-treat PSVT episodes, the design, procedure, timing, scope and results of the NODE-302 extension study; Milestone's ability to execute on the remainder of the PSVT program and Milestone's ongoing plans to study etripamil in atrial fibrillation patients. 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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