- Preclinical results show potential
first-in-class disease-modifying properties of sotatercept in
pulmonary arterial hypertension -
- Company expects to initiate a Phase 2 trial
in 1H 2018 -
Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical
company in the discovery and development of TGF-beta therapeutics
to treat serious and rare diseases, today announced new preclinical
results with sotatercept in pulmonary arterial hypertension (PAH)
during an oral presentation at the American Heart Association (AHA)
2017 Scientific Sessions in Anaheim, California.
“We are extremely encouraged by these positive preclinical
results, which support our mechanistic approach for sotatercept and
its potential to be a first-in-class disease-modifying therapy for
patients with pulmonary arterial hypertension. We look forward to
initiating a Phase 2 trial with sotatercept in PAH during the first
half of 2018,” said Ravi Kumar, Chief Scientific Officer for
Acceleron.
The oral presentation by Paul Yu, M.D., Ph.D., Associate
Professor of Medicine, Brigham and Women’s Hospital, entitled
“ACTRIIA-Fc rebalances BMP and activin/TGFβ signaling to attenuate
experimental pulmonary hypertension,” provided data from three
animal models of PAH demonstrating potent effects of sotatercept on
many aspects of vascular and cardiac disease.
- In animals treated early in disease
progression, sotatercept blocked the development of pulmonary
vascular remodeling and right heart failure, and prevented the
increase in pulmonary arterial pressure.
- For animals treated after established
disease, sotatercept achieved a marked reduction in intimal-medial
thickness of pulmonary arterioles relative to untreated animals,
decreased vessel muscularization, improved pulmonary arterial
pressures and decreased indicators of right heart failure.
“The sotatercept preclinical results show remarkable biological
activity, particularly on the pulmonary vasculature, across
multiple, well-established animal models of PAH,” said Dr. Yu.
“These results are very exciting, and further establish the
importance of signaling by the TGF-beta superfamily as a target for
therapies to treat PAH.”
Sotatercept is an investigational product that is not approved
for use in any country.
The AHA preclinical presentation is available under the Science
page of the Company's website at www.acceleronpharma.com.
About Sotatercept
Sotatercept is an activin receptor type IIA fusion protein that
acts as a ligand trap for members in the transforming growth
factor-beta superfamily involved in remodeling and regeneration of
a variety of different tissues, including the vasculature and
fibrosis.
About Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (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 Cambridge-based, clinical-stage biopharmaceutical
company dedicated to the discovery, development, and
commercialization of therapeutics to treat serious and rare
diseases. The Company’s leadership in the understanding of TGF-beta
biology and protein engineering generates innovative compounds that
engage the body’s ability to regulate cellular growth and
repair.
Acceleron focuses its research and development efforts in
hematologic, neuromuscular, and pulmonary diseases. In hematology,
the Company and its global collaboration partner, Celgene, are
developing luspatercept for the treatment of chronic anemia in
myelodysplastic syndromes, beta-thalassemia, and myelofibrosis.
Acceleron is also advancing its neuromuscular franchise with two
distinct Myostatin+ agents, ACE-083 and ACE-2494, and a pulmonary
program with a Phase 2 trial of sotatercept planned in pulmonary
arterial hypertension.
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 the
Company's strategy, future plans and prospects, including
statements regarding the development of the Company's compounds,
the timeline for clinical development and regulatory approval of
the Company’s compounds and the expected timing for reporting of
data from ongoing clinical trials. The words "anticipate,"
"believe," "could," "estimate," "expect," "goal," "intend," "may,"
"plan," "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 risks and
uncertainties, including, but not limited to, that preclinical
testing of the Company's compounds and data from clinical trials
may not be predictive of the results or success of ongoing or later
clinical trials, that the development of the Company's compounds
will take longer and/or cost more than planned, that the Company or
its collaboration partner, Celgene, will be unable to successfully
complete the clinical development of the Company’s compounds, that
the Company or Celgene may be delayed in initiating, enrolling or
completing any clinical trials, and that the Company's compounds
will not receive regulatory approval or become commercially
successful products. These and other risks and uncertainties are
identified under the heading "Risk Factors" included in the
Company's most recent Annual Report on Form 10-K, and other filings
that the Company 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 the
Company does not undertake and specifically disclaims any
obligation to update any forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20171114006527/en/
Acceleron Pharma Inc.Todd James, IRC, 617-649-9393Vice
President, Investor Relations and Corporate CommunicationsOrCandice
Ellis, 617-649-9226Manager, Investor Relations and Corporate
CommunicationsOrMedia:BMC CommunicationsBrad Miles,
646-513-3125
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