Milestone Pharmaceuticals Announces Late-Breaking Presentation of Data from Phase 3 RAPID Clinical Trial of Etripamil Nasal Spray in Patients with Paroxysmal Supraventricular Tachycardia at the American Heart Association Scientific Sessions 2022

MONTREAL and CHARLOTTE, N.C., Oct. 25, 2022 /CNW/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that data from the Phase 3 RAPID clinical trial of self-administered etripamil in patients with paroxysmal supraventricular tachycardia (PSVT) in the at-home setting will be featured during a Late-Breaking Clinical Trials session at the American Heart Association Scientific Sessions 2022 taking place November 5-7, 2022 in Chicago, IL and virtually. Etripamil, a new chemical entity, is Milestone's lead investigational product.

The Late-Breaker presentation details are:

Title: Self-Administered Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia: Primary Analysis From the RAPID Study
Presentation number: 19625
Session number: LBS.08
Session Title: Late-Breaking Science: Treating Atrial and Supraventricular Arrhythmias
Presenter: James Ip, M.D., Associate Professor and Director of Cardiac Pacing and Implantable Devices, Division of Cardiology, Weill Cornell Medicine, New York Presbyterian Hospital, on behalf of Bruce Stambler, M.D., F.H.R.S, Director of Cardiac Arrhythmia Research and Education, Piedmont Heart Institute, Atlanta, GA and all co-authors.
Date and Time: Monday, November 7, 2022 from 11:13-11:23 a.m. CT

In addition, data from the previously completed Phase 3 NODE-301 trial will be featured in a poster presentation session, the details of which are:

Title: Patient-Reported Treatment Satisfaction in Etripamil-Mediated Conversion of Supraventricular Tachycardia to Sinus Rhythm: Results From the NODE-301 Study
Presentation Number: MO4023
Session Title: Benefits and Risks Associated with Arrhythmia Management
Presenter: James Ip, M.D., Associate Professor and Director of Cardiac Pacing and Implantable Devices, Division of Cardiology, Weill Cornell Medicine, New York Presbyterian Hospital, on behalf of all co-authors.
Date and Time: Monday, November 7, 2022 from 11:00 a.m.-12:00 p.m. CT

About Paroxysmal Supraventricular Tachycardia

Paroxysmal supraventricular tachycardia (PSVT) is a condition affecting approximately two million Americans that is characterized by intermittent episodes of a rapid heartbeat that starts and stops suddenly. Episodes of supraventricular tachycardia (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 long been used for the acute treatment of PSVT. However, these medications must be administered under medical supervision, usually in an emergency department or other acute care setting.

About Etripamil

Etripamil, a new chemical entity, is Milestone's lead investigational product. It 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 a Phase 2 proof-of-concept trial that is underway in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR).

About Milestone Pharmaceuticals

Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines. Milestone's lead product candidate etripamil is currently in a Phase 3 clinical-stage program for the treatment of paroxysmal supraventricular tachycardia (PSVT) and in a Phase 2 proof-of-concept trial for the treatment of patients with atrial fibrillation with rapid ventricular rate (AFib-RVR). Milestone Pharmaceuticals operates in Canada and the United States. For more information, visit www.milestonepharma.com and follow Milestone on Twitter at @MilestonePharma.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "continue," "could," "design," "develop," "estimate," "expect," "further," "look forward," "ongoing," "plan," "potential," "progress," "will," "would," 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 efficacy, safety and tolerability of etripamil; the potential of etripamil to deliver a clinically meaningful benefit to patients with PSVT in the home-setting environment and to empower patients to take control of their condition as well as provide value to the healthcare system; the design, progress, timing, scope and results of the RAPID trial; Milestone's ability to execute on the remainder of the PSVT program; the presentation and publication of unblind RAPID results and topline data with respect to the Company's RAPID trial and the timing of such presentation and publication; the timing of Milestone's NDA application, the ability of the results from the RAPID study to fulfil the efficacy requirements of such NDA application and the timing of agency feedback on the application; and 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; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT, AFib-RVR 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 U.S. Securities and Exchange Commission, including in its annual report on Form 10-K for the year ended December 31, 2021, under the caption "Risk Factors," as such discussion may be updated from time to time by subsequent filings Milestone may make with the U.S. Securities & Exchange Commission. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact

David Pitts
Argot Partners
212-600-1902
[email protected]

SOURCE Milestone Pharmaceuticals, Inc.