- Self-administration of etripamil in
patients experiencing AFib-RVR episodes resulted in a substantial
reduction in ventricular rate which was sustained over 60
minutes
- Data featured in an oral session at
the Heart Rhythm 2023 Annual Meeting
- Company to host virtual KOL conference
call and webcast to discuss etripamil development for the treatment
of AFib-RVR today at 8:00 a.m.
ET
MONTREAL and CHARLOTTE,
N.C., May 22, 2023 /PRNewswire/ -- Milestone
Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company
focused on the development and commercialization of innovative
cardiovascular medicines, today announced promising data from an ad
hoc analysis of a subset of patients experiencing atrial
fibrillation with rapid ventricular rate (AFib-RVR) in the NODE-303
study, which evaluated etripamil, the Company's investigational
calcium channel blocker, in patients with paroxysmal
supraventricular tachycardia (PSVT). The data were featured during
an oral session at the Heart Rhythm 2023 Annual Meeting.
"Data from this unplanned analysis represent the first direct
clinical evidence of the impact of etripamil on heart rate in
patients experiencing an event of AFib-RVR," said Joseph Oliveto, President and Chief Executive
Officer of Milestone Pharmaceuticals. "We look forward to sharing
topline results from our ongoing Phase 2, placebo-controlled study
in patients with AFib-RVR, which we expect to report in the second
half of 2023. We are firmly committed to our mission of unlocking
the full potential of etripamil to serve as a self-administered,
on-demand treatment for patients facing episodic cardiovascular
conditions associated with rapid heart rate."
"AFib-RVR frequently causes severe symptoms and anxiety. Slowing
the heart rate quickly can offer considerable relief from both
symptoms and associated concerns. Etripamil nasal spray, an
investigational treatment, would be the only self-administered
medication available which suits this purpose," said lead author
Paul Dorian, MD, MSC, Professor of
Medicine & Pharmacology, University of
Toronto; Staff Cardiac Electrophysiologist, St. Michael's Hospital. "These initial results
are encouraging and support further clinical development of
etripamil and highlight the potential of etripamil to offer
patients a valuable option to manage their AFib-RVR episodes
outside of the stressful and costly acute-care setting."
Overview of Data
The open-label Phase 3 NODE-303 global safety study evaluated
self-administered etripamil in patients with PSVT. Based on expert
review of ambulatory electrocardiogram (ECG) data collected for
1024 treated episodes, 21 of the episodes in 18 patients were
determined to be attributed to AFib-RVR rather than PSVT.
Of the 21 AFib-RVR episodes analyzed, 17 had a ventricular rate
(VR) ≥110 bpm at baseline. After self-administering etripamil,
average-reductions in VR from baseline were determined throughout
the 60-minute post-administration window, with 6 episodes
converting to sinus rhythm. Results demonstrate a maximum reduction
(± SEM) of -27.4 ± 6.1 bpm at 22 minutes, and -16.2 ± 5.6 bpm at 60
minutes.
The safety and tolerability data from the analysis of these
AFib-RVR episodes were consistent with those observed across prior
studies in PSVT. The most common treatment-related adverse events
(AEs) were related to the nasal administration site. Overall, the
majority of AEs were reported as mild to moderate, and there were
no reported serious AEs related to etripamil. Results of this ad
hoc analysis may be limited due to time of study-drug
administration variability related to the start of ECG recording
and enrollment of patients with an existing history of
supraventricular tachycardia, which may not be representative of
the entire AFib population.
Enrollment continues in ReVeRA, Milestone's Phase 2
double-blind, placebo-controlled, proof-of-concept trial of
etripamil nasal spray in emergency-department patients experiencing
AFib-RVR. The trial, in which patients are randomized 1:1 to
receive either 70 mg of etripamil or placebo, is designed to assess
the safety and efficacy of etripamil nasal spray 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. Milestone expects to
report topline data from this trial in the second half of 2023.
Conference Call and Webcast
The Company will host a virtual Key Opinion Leader (KOL) event
today, Monday, May 22, 2023 at
8:00 a.m. ET. The event will feature
a review of the HRS data, as well as an overview of AFib-RVR, the
current treatment landscape, characteristics of etripamil, and
commentary on next steps for Milestone's etripamil clinical
development program. Joining the Company's management team will be
Paul Dorian, MD, MSC, Professor of
Medicine, Departments of Medicine and Pharmacology, University of Toronto; Staff Cardiac
Electrophysiologist, St. Michael's
Hospital, and Jonathan P. Piccini,
MHS, MD, FHRS, Professor of Medicine & Population Health,
Director, Cardiac Electrophysiology, Duke
University & Duke Clinical Research Institute.
To access a live or recorded webcast of the KOL event and
accompanying slides, please visit the News & Events section of
Milestone's website at www.milestonepharma.com. To access the
live call by phone, dial (877) 870-4263 (domestic) or (412)
317-0790 (international) and ask to be connected to the Milestone
Pharmaceuticals call. The recorded webcast and slides will be
available on the Company's website following the call.
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 United
States, a prevalence projected by the Centers for
Disease Control to increase to twelve million patients by
2030. Atrial fibrillation with rapid ventricular rate (AFib-RVR) is
a condition that many patients with AFib experience and includes
episodes of abnormally high heart rate, often with symptoms of
palpitations, shortness of breath, dizziness, and weakness. Oral
calcium channel blockers and/or beta blockers are used to reduce
the heart rate in this condition. When AFib-RVR occurs, symptoms
are often burdensome enough to cause patients to seek acute care in
the emergency department, where standard-of-care procedures include
intravenous administration of calcium channel blockers or beta
blockers, or electrical cardioversion, under medical supervision.
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 Paroxysmal Supraventricular Tachycardia
Paroxysmal Supraventricular Tachycardia (PSVT) is a highly
symptomatic and impactful heart arrhythmia characterized by
unpredictable attacks of a racing heart that afflicts approximately
two million Americans. Symptoms of PSVT, including palpitations,
chest pressure, and shortness of breath are often debilitating,
causing the patient to stop their current activities or avoid
pursuits altogether. The impact and morbidity from an attack can be
especially detrimental in patients with underlying cardiovascular
or medical conditions, such as heart failure, obstructive coronary
disease, or dehydration. The uncertainty of when an episode of SVT
will strike or how long it will persist can provoke anxiety in
patients, which can have a negative impact on their day-to-day
life. Many doctors are unsatisfied by the lack of effective
treatment options besides a prolonged, unpleasant, and costly trip
to the emergency department or, for some patients, an invasive
ablation procedure.
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.
Milestone is conducting a comprehensive development program for
etripamil, with Phase 3 trials completed and an NDA soon to be
submitted in the third quarter of 2023 in paroxysmal
supraventricular tachycardia (PSVT). Milestone also has a Phase 2
proof-of-concept trial that is ongoing in patients experiencing
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 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 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," "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 potential of etripamil to serve as a promising
therapy for PSVT patients; the timing of the NDA submission for
etripamil nasal spray; the potential for clinical trial data from
the Phase 2 ReVeRA program in the second half of 2023 etripamil's
further clinical development and potential to offer patients a
valuable option to manage their AFib-RVR episodes; and our ability
to continue enrollment in ReVeRA. 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 it 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
milestone@argotpartners.com
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SOURCE Milestone Pharmaceuticals, Inc.