– Presentation of cardiac and pulmonary
function data from the ongoing PULSAR Phase 2 trial receives AHA’s
“Cardiopulmonary Best Abstract” Award –
– AHA sessions to include data from the ongoing
SPECTRA Phase 2 trial –
– Acceleron to host investor and analyst
conference call and webcast with guest PAH key opinion leaders on
Friday, November 13, at 11:00 a.m. EST –
Acceleron Pharma Inc. (Nasdaq:XLRN), a leading biopharmaceutical
company in the discovery, development, and commercialization of
TGF-beta superfamily therapeutics to treat serious and rare
diseases, today announced that updates from the ongoing PULSAR and
SPECTRA Phase 2 clinical trials of sotatercept in patients with
pulmonary arterial hypertension (PAH) will be presented at the
American Heart Association (AHA) 2020 Scientific Sessions, held
virtually November 13-17. The Company will also present preclinical
research on the effects of a murine version of sotatercept in an
animal model of PAH.
The presentation of the PULSAR trial echocardiography data,
which earned the AHA’s “Cardiopulmonary Best Abstract” award, will
focus on sotatercept’s effects on cardiac right ventricular
function in conjunction with pulmonary arterial pressure in
patients with PAH. The results build upon the positive efficacy and
safety results reported earlier this year during the Breaking News
Session of the American Thoracic Society 2020 Virtual
Conference.
The AHA Scientific Sessions will also include data from the
SPECTRA Phase 2 trial as part of an invited talk by Principal
Investigator Aaron Waxman, M.D., Ph.D., Director, Pulmonary
Vascular Disease Program at Boston’s Brigham and Women’s Hospital.
Dr. Waxman will discuss characteristics and selected outcomes from
the first 10 patients with PAH participating in this ongoing trial
assessing the effect of sotatercept on peak oxygen uptake, as
measured by invasive cardiopulmonary exercise testing.
“We’re thrilled to be able to showcase more clinical and
preclinical research on sotatercept during the AHA Scientific
Sessions,” said Habib Dable, President and Chief Executive Officer
of Acceleron. “The findings to be presented further solidify our
belief that sotatercept acts via a unique mechanism to reverse
pulmonary vascular remodeling, lending it the potential to become a
backbone therapy for patients with PAH.”
Clinical Presentations
Cardiopulmonary Best Abstract Award:
Title:
Sotatercept Improves Right Ventricular
- Pulmonary Arterial Coupling and Right Ventricular Function in the
PULSAR Study: A Phase 2, Double-blind, Placebo-controlled,
Randomized Study to Compare the Efficacy and Safety of Sotatercept
versus Placebo When Added to Standard of Care for the Treatment of
Pulmonary Arterial Hypertension (PAH)
Session:
Dickinson W. Richards Memorial Lecture
Abstract:
287
Invited Talk:
Title:
SPECTRA and Beyond: Signs of Disease
Modification?
Session:
Pulmonary Hypertension Clinical Trials
with Novel Approaches
Preclinical Presentation
Title:
Sotatercept Analog RAP-011 Inhibits
Right Ventricular Remodeling and Restores Function in a Mouse Model
of Pressure Overload
Session:
Targeting Right Ventricular Dysfunction in
PAH
Abstract:
MP282
All of the above presentations will be available to conference
registrants for viewing on the AHA Scientific Session’s Virtual
Platform beginning November 13, 2020 at 10:00am EST and will
available on the Virtual Platform through November 17, 2020 at
9:30pm EST. The presentations will also be posted to the
“Publications” page under the “Science & Pipeline” section on
Acceleron’s website, www.acceleronpharma.com, beginning November
13, 2020 at 10:00 a.m. EST.
Webcast and Conference Call Information
The Company will host a webcast and conference call to review
the presentations of sotatercept at AHA on November 13, 2020, at
11:00 a.m. EST.
The webcast will be accessible under “Events &
Presentations” in the Investors/Media page of the company's website
at www.acceleronpharma.com. Individuals can participate in the live
conference call by dialing 877-312-5848 (domestic) or 253-237-1155
(international) and referring to the “AHA Sotatercept Conference
Call.”
A replay of the webcast will be available on the Acceleron
website approximately two hours after the event.
About Sotatercept
Sotatercept is an investigational reverse-remodeling agent
designed to be a selective ligand trap for members of the TGF-beta
superfamily to rebalance BMPR-II signaling, which is a key
molecular driver of PAH. The PULSAR Phase 2 trial evaluating
sotatercept in combination with approved PAH-specific medicines in
patients with PAH achieved its primary endpoint of improvement in
pulmonary vascular resistance and its key secondary endpoint of
improvement in 6-minute walk distance. Sotatercept was generally
well tolerated in the trial. Adverse events observed in the study
were generally consistent with previously published data on
sotatercept in other diseases. Following the PULSAR results,
sotatercept was granted Breakthrough Therapy designation from the
FDA and Priority Medicines designation from the EMA in PAH.
Sotatercept is also being evaluated in the SPECTRA Phase 2
exploratory trial.
In preclinical research published in Science Translational
Medicine, sotatercept exhibited consistent effects across multiple
components of disease, including suppressed proliferation of
pulmonary arterial smooth muscle and microvascular endothelial
cells, reduced pulmonary pressures, lessened right ventricular
hypertrophy, improved right ventricular function, and attenuated
vascular remodeling.
The Company recently presented details of its Phase 3
development plan, including the design for the registrational
STELLAR trial, which is expected to be initiated before the end of
2020.
Sotatercept is an investigational therapy that is not approved
for any use in any country. Sotatercept is part of a licensing
agreement with Bristol Myers Squibb.
About PAH
PAH is a rare and chronic, rapidly progressing disorder
characterized by the constriction of small pulmonary arteries and
elevated blood pressure in the pulmonary circulation. PAH results
in significant strain on the heart, often leading to limited
physical activity, heart failure, and reduced life expectancy. The
5-year survival rate for patients with PAH is approximately 57%.
Available therapies generally act by promoting the dilation of
pulmonary vessels without addressing the underlying cause of the
disease. As a result, PAH often progresses rapidly for many
patients despite standard of care treatment. A growing body of
research has implicated imbalances in BMP and TGF-beta signaling as
a primary driver of PAH in familial, idiopathic, and acquired forms
of the disease.
About Acceleron
Acceleron is a biopharmaceutical company dedicated to the
discovery, development, and commercialization of therapeutics to
treat serious and rare diseases. Acceleron’s leadership in the
understanding of TGF-beta superfamily biology and protein
engineering generates innovative compounds that engage the body's
ability to regulate cellular growth and repair.
Acceleron focuses its commercialization, research, and
development efforts in hematologic and pulmonary diseases. In
hematology, REBLOZYL® (luspatercept-aamt) is the first and only
erythroid maturation agent approved in the United States, Europe,
and Canada for the treatment of anemia in certain blood disorders.
REBLOZYL is part of a global collaboration partnership with Bristol
Myers Squibb. The Companies co-promote REBLOZYL in the United
States and are also developing luspatercept for the treatment of
anemia in patient populations of MDS, beta-thalassemia, and
myelofibrosis. In pulmonary, Acceleron is developing sotatercept
for the treatment of pulmonary arterial hypertension (PAH), having
recently presented positive topline results of the Phase 2 PULSAR
trial. The Company is currently planning multiple Phase 3 trials
with the potential to support its long-term vision of establishing
sotatercept as a backbone therapy for patients with PAH at all
stages of the disease.
For more information, please visit www.acceleronpharma.com.
Follow Acceleron on Social Media: @AcceleronPharma and
LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements about
Acceleron’s strategy, future plans and prospects, including
statements regarding the development of sotatercept in PAH, the
timeline for clinical development and regulatory approval of
sotatercept in PAH, the expected timing for reporting of data from
ongoing clinical trials, and the potential of Acceleron’s compounds
as therapeutic drugs. The words "anticipate," "believe," "could,"
"estimate," "expect," "goal," "intend," "may," "plan," “possible,”
"potential," "project," "should," "target," "will," "would," and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words.
Actual results could differ materially from those included in
the forward-looking statements due to various factors, risks and
uncertainties, including, but not limited to, that preclinical
testing of Acceleron’s compounds and data from clinical trials may
not be predictive of the results or success of ongoing or later
clinical trials, that regulatory approval of Acceleron’s compounds
in one indication or country may not be predictive of approval in
another indication or country, that the development of Acceleron’s
compounds will take longer and/or cost more than planned, that
Acceleron will be unable to successfully complete the clinical
development of Acceleron’s compounds, that Acceleron may be delayed
in initiating, enrolling or completing any clinical trials, that
Acceleron’s compounds will not receive regulatory approval or
become commercially successful products, and that Breakthrough
Therapy or PRIME designation may not expedite the development or
review of sotatercept. These and other risks and uncertainties are
identified under the heading “Risk Factors” included in Acceleron’s
most recent Annual Report on Form 10-K, Quarterly Report on Form
10-Q, and other filings that Acceleron has made and may make with
the SEC in the future.
The forward-looking statements contained in this press release
are based on management's current views, plans, estimates,
assumptions, and projections with respect to future events, and
Acceleron does not undertake and specifically disclaims any
obligation to update any forward-looking statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201109005307/en/
Investors: Jamie Bernard, IRC, 617-649-9650 Associate Director,
Investor Relations
Media: Matt Fearer, 617-301-9557 Director, Corporate
Communications
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