– Conference to include interim results from
the open-label extension of the PULSAR Phase 2 trial showing
consistent or improved responses in efficacy endpoints among
sotatercept-treated patients –
– Interim results from the SPECTRA Phase 2
trial to show improvements in measures of exercise hemodynamics
–
– Sotatercept was generally well tolerated in
both trials, consistent with the previously reported safety profile
in PAH and in other diseases –
– Acceleron to host investor and analyst
conference call and webcast on Wednesday, May 19 –
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
PULSAR and SPECTRA Phase 2 clinical trials of sotatercept in
patients with pulmonary arterial hypertension (PAH) will be
presented at the American Thoracic Society 2021 International
Conference (ATS 2021), held virtually May 14-19. The Company will
also present preclinical research on the effects of a murine
version of sotatercept in animal models of PAH and pulmonary
hypertension.
ATS 2021 will include interim results from the open-label
extension of the PULSAR Phase 2 trial through 48 weeks. The
presentation will highlight changes from baseline in a range of
endpoints, including six-minute walk distance and World Health
Organization (WHO) functional class. The conference will also
feature interim data from the SPECTRA Phase 2 trial assessing the
effect of sotatercept on peak oxygen uptake and exercise
hemodynamics, as measured by invasive cardiopulmonary exercise
testing.
“It’s quite gratifying to return to the ATS International
Conference with new sotatercept data, having first presented
topline results from the PULSAR trial during a special breaking
news session at ATS 2020 Virtual,” said Habib Dable, President and
Chief Executive Officer of Acceleron. “The results to be shared
this year strengthen our confidence in sotatercept’s potential to
become a backbone therapy for patients with PAH.”
Clinical Presentations
Session: Come Together – Clinical Advances in Pulmonary
Hypertension: Lesson from Best Abstracts
Date: Wed, May 19, 8:00 - 9:30 a.m. EDT
Title: PULSAR Study Open-Label Extension: Interim Results
from a Phase 2 Study of the Efficacy and Safety of Sotatercept When
Added to Standard of Care for the Treatment of Pulmonary Arterial
Hypertension (PAH)
Title: The SPECTRA Study: A Phase 2a Single-Arm, Open-Label,
Multicenter Exploratory Study to Assess the Effects of Sotatercept
for the Treatment of Pulmonary Arterial Hypertension (PAH)
The PULSAR and SPECTRA presentations will include additional
data and analyses not disclosed in the abstracts.
Preclinical ePoster
Presentations
Session: A Hard Day’s Night – Novel Molecular Mechanisms and
Treatment Options in PAH and Beyond: From Pulmonary Vasculature to
RV
Title: Sotatercept Analog RAP-011 Alleviates Cardiopulmonary
Remodeling and Inflammation in a Model of Heritable PAH Arising
from Bmpr2 Haploinsufficiency
Title: Sotatercept Analog RAP-011 Reduces Right Ventricular
Hypertrophy and Alleviates Pulmonary Hypertension in A ZSF1 Rat
Model of Heart Failure with Preserved Ejection Fraction
All of the abstracts above are currently viewable on the ATS
website.
The preclinical presentations will be posted to the
“Publications” page under the “Science & Pipeline” section on
Acceleron’s website, www.acceleronpharma.com, beginning Friday, May
14, with the clinical presentations being added to the Acceleron
website on Wednesday, May 19 at 9:30 a.m. EDT.
Webcast and Conference Call Information
The Company will host a webcast and conference call to review
the presentations of sotatercept at ATS 2021 on Wednesday, May 19,
2021.
The webcast will be accessible under “Events &
Presentations” on the Investors & Media page of the Company's
website at www.acceleronpharma.com. Additional details, including
specific timing and call-in information will be announced prior to
the presentations at ATS 2021.
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.
The Company recently presented details of its Phase 3
development plan, including the design for the registrational
STELLAR trial, which is currently enrolling patients with PAH.
Acceleron is planning two additional Phase 3 studies in patients
with PAH: the HYPERION trial in newly diagnosed patients and the
ZENITH trial assessing intervention in patients diagnosed with
World Health Organization (WHO) functional class IV disease.
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 research, development, and
commercialization efforts in pulmonary and hematologic diseases. In
pulmonary, Acceleron is developing sotatercept for the treatment of
pulmonary arterial hypertension (PAH), having reported positive
topline results of the PULSAR Phase 2 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. Acceleron is also investigating the potential of its
early-stage pulmonary candidate, ACE-1334, which it plans to
advance into a Phase 1b/Phase 2 trial in systemic
sclerosis-associated interstitial lung disease (SSc-ILD) this
year.
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 myelodysplastic
syndromes, beta-thalassemia, and myelofibrosis.
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 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/20210405005179/en/
Investors: Jamie Bernard, IRC, 617-301-9650 Associate Director,
Investor Relations
Media: Matt Fearer, 617-301-9557 Senior Director, Corporate
Communications
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