MONTREAL and CHARLOTTE,
N.C., Sept. 27, 2023 /PRNewswire/ -- Milestone
Pharmaceuticals Inc. (Nasdaq: MIST) today announced that results
from a double-blind, randomized, placebo-controlled Phase 2
etripamil study will be presented at the American Heart Association
(AHA) Scientific Sessions 2023. Selected for a Featured Science
Presentation, the ReVeRA study evaluated etripamil in emergency
department patients with atrial fibrillation with rapid ventricular
rate (AFib-RVR). The presentation will take place at the AHA
Scientific Sessions in Philadelphia,
PA and virtually from November 11-13,
2023.
"Current AFib-RVR treatment goals include quickly resolving the
discomfort and disruption of episodes of rapid heart rate. We're
optimistic that the data will demonstrate etripamil's potential to
meet this goal for patients who have limited options to self-manage
their disease," said David Bharucha,
M.D., Ph.D., F.A.C.C., Chief Medical Officer of Milestone
Pharmaceuticals. "This is an important step in understanding the
potential clinical utility of etripamil in indications beyond our
lead program in paroxysmal supraventricular tachycardia."
The Feature Science presentation details are:
Session Title: Featured Science:
Innovations in EP Care
Session number: FS.01
Presenter: A. John Camm, M.D., British Heart Foundation
Emeritus Professor of Clinical Cardiology, The Cardiology Clinical
Academic Group, Molecular and Clinical Sciences Research Institute,
St. George's University of
London, London, UK
Title: Randomized, Controlled Study of the Efficacy and
Safety of Etripamil Nasal Spray for the Acute Reduction of Rapid
Ventricular Rate in Patients with Symptomatic Atrial Fibrillation
(Phase 2, ReVeRA-201)
Time, Date: 9:57-10:05 AM
ET, Saturday, November 11,
2023
About ReVeRA
ReVeRA is a Phase 2 double-blind, randomized,
placebo-controlled, proof-of-concept trial of etripamil in patients
presenting to an emergency department with AFib-RVR. The trial, in
which patients were randomized 1:1 to receive either etripamil
nasal spray 70 mg or placebo, is designed to assess the safety and
efficacy of etripamil to reduce elevated ventricular rates in
patients with symptomatic AFib-RVR. The primary endpoint will
assess reduction in ventricular rate, with key secondary endpoints
including the time to achieve the maximum reduction in rate and
duration of the effect.
About Atrial Fibrillation with Rapid Ventricular Rate
An estimated five million Americans suffer from
AFib, a common arrhythmia marked by an irregular, disruptive and
often rapid heartbeat. The Centers for Disease Control projects the
prevalence of AFib will grow to an estimated 12 million patients by
2030. A subset of AFib patients experience episodes of abnormally
high heart rate most often accompanied by palpitations, shortness
of breath, dizziness, and weakness. While these episodes, known as
AFib-RVR, may be treated by oral calcium channel blockers and/or
beta blockers, patients frequently seek acute care in the emergency
department (ED) to resolve symptoms. In 2016, nearly 800,000
patients were admitted to the ED due to AFib symptoms where
treatment includes medically supervised intravenous administration
of calcium channel blockers or beta blockers, or electrical
cardioversion. With little available data for AFib-RVR, Milestone's
initial market research indicates that 30-40% of patients with AFib
experience one or more symptomatic episodes of RVR per year that
require treatment, suggesting a target addressable market of
approximately three to four million patients in 2030 for etripamil
in patients with AFib.
About Etripamil
Etripamil, Milestone's lead investigational
product, is a novel calcium channel blocker nasal spray. It is
designed to be a rapid-response therapy that is self-administered
by the patient, without the need for direct medical oversight, and
is being developed for elevated and often highly symptomatic heart
rate attacks associated with PSVT and AFib-RVR. If approved,
etripamil is intended to provide health care providers with a new
tool to enable virtual care and patient self-management, and to
impart upon the patient a greater sense of control over their
condition. Etripamil is well studied with a robust clinical trial
program that includes a completed Phase 3 clinical-stage program
for the treatment of PSVT and soon to be reported Phase 2
proof-of-concept trial for the treatment of patients with
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 recently completed its
Phase 3 clinical-stage program for the treatment of paroxysmal
supraventricular tachycardia (PSVT) and is in a Phase 2
proof-of-concept trial for the treatment of patients with
AFib-RVR. Milestone Pharmaceuticals operates
in Canada and the United
States. Find out more at www.milestonepharma.com.
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," "demonstrate,"
"designed," "develop," "estimate," "expect," "may," "pending,"
"plan," "potential," "progress," "will" 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 ability of the data from the ReVeRa study to
demonstrate etripamil's potential to meet certain goals for
patients with AFib-RVR; the ability of the data from the ReVeRa
study to provide an important step in understanding the potential
clinical utility of etripamil in indications beyond our lead
program in paroxysmal supraventricular tachycardia; the ability of
the ReVeRa study to assess reduction in ventricular rate; growth in
the number of AFib patients by 2030; the potential of etripamil to
serve as a promising therapy for PSVT patients; and the timing of
clinical trial data from the Phase 2 etripamil study. 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, evaluation and
results of our 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 or other indications, among others,
general economic, political, and market conditions, including
deteriorating market conditions due to investor concerns regarding
inflation and Russian hostilities in Ukraine and overall fluctuations in the
financial markets in the United
States and abroad, risks related to pandemics and public
health emergencies, and risks related the sufficiency of
Milestone's capital resources and its ability to raise additional
capital in the current economic climate. 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, 2022,
under the caption "Risk Factors," as such discussion may be updated
from time to time by subsequent filings we 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
Kim Fox, Vice
President, Communications
kfox@milestonepharma.com
704-803-9295
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SOURCE Milestone Pharmaceuticals, Inc.