– RAPID and completed NODE-301 studies could potentially
fulfill efficacy requirement for future NDA for etripamil in
patients with PSVT –
– RAPID investigates efficacy of second dose of
etripamil for patients with persistent PSVT –
– RAPID results expected late 2021/early 2022 –
MONTREAL and CHARLOTTE, N.C., Nov. 18, 2020 /CNW/ -- Milestone
Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical
company focused on the development and commercialization of
innovative cardiovascular medicines, today announced that the first
patient has been enrolled in RAPID, a pivotal Phase 3 trial of
etripamil nasal spray. Etripamil is a novel, short-acting calcium
channel blocker in development for the treatment of patients with
paroxysmal supraventricular tachycardia (PSVT).
"Commencement of RAPID marks an important milestone for the PSVT
etripamil program," said Joseph
Oliveto, President and Chief Executive Officer of Milestone
Pharmaceuticals. "We remain very encouraged by physicians'
reactions to the safety and efficacy results from the NODE-301
trial and believe the RAPID trial has the potential to demonstrate
increased efficacy and improved overall clinical utility of
etripamil. We appreciate and thank the clinical investigators,
trial coordinators, etripamil trial team, and patients for their
contributions and continued support of RAPID."
The RAPID trial is expected to randomize up to 500 patients and
will be completed after a total of 180 confirmed supraventricular
tachycardia (SVT) events are reached. Patients in the RAPID trial
will be randomized 1:1 to etripamil or placebo. To maximize the
potential treatment effect of etripamil, patients who do not
experience symptom relief within 10 minutes of the first study drug
administration will be directed to administer a second dose of
study drug.
As previously announced, the primary efficacy endpoint for both
the RAPID and NODE-301 trials will be time to conversion of SVT
within 30 minutes following initial study drug administration, with
a target p-value of less than 0.05 for each trial. Milestone
expects to report data from the RAPID trial in late 2021/early
2022.
About Paroxysmal Supraventricular Tachycardia
PSVT is a rapid heart rate condition characterized by
intermittent episodes of SVT that start and stop suddenly and
without warning. 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 calcium channel blockers have long
been approved for the treatment of PSVT as well as other cardiac
conditions. However, calcium channel blockers approved for the
termination of SVT episodes must be administered intravenously
under medical supervision, usually in an emergency department or
other acute care setting.
About Etripamil
Etripamil, the Company's lead investigational product, is
designed to be a rapid-response therapy for episodic cardiovascular
conditions. The novel calcium channel blocker is self-administered
via a nasal spray, which may shift the current treatment paradigm
for many patients with PSVT from the emergency department to the
at-home setting. Milestone is conducting a comprehensive
development program for etripamil, with Phase 3 trials underway in
PSVT, and plans to commence a Phase 2 proof-of-concept trial in
patients with atrial fibrillation with rapid ventricular rate, with
subsequent studies expected in other conditions where calcium
channel blockers are used.
About Milestone Pharmaceuticals
Milestone Pharmaceuticals is a biopharmaceutical company
focused on the development and commercialization of etripamil, a
Phase 3 clinical-stage program, for the treatment of cardiovascular
indications. Milestone Pharmaceuticals operates
in Canada and the United
States. For more information,
visit www.milestonepharma.com and follow the Company 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 "may," "will," "expect," "plan," "anticipate,",
"continue" "estimate," "potential,", "prepare", "believe,"
"remain," "intend" 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 (i)
the design, progress, timing, scope and results of the RAPID trial,
(ii) potential clinical trials in other cardiac conditions and
(iii) the possibility that data will support FDA approval.
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, including the RAPID trial, 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 COVID-19, 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 quarterly report on Form 10-Q for the quarter
ended September 30, 2020, under the caption "Risk Factors."
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
david@argotpartners.com
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SOURCE Milestone Pharmaceuticals, Inc.