Acceleron Showcases Vision and Strategy at 2017 R&D Day
19 Septiembre 2017 - 10:30AM
Business Wire
- Clinical development and research efforts
focused on hematological, neuromuscular and pulmonary diseases
–
Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical
company in the discovery and development of TGF-beta therapeutics
to treat serious and rare diseases, hosted its Research and
Development (R&D) Day in New York City today. The Company
discussed clinical development plans to build therapeutic area
leadership, and its long-term strategy to advance key programs in
hematologic, neuromuscular, and pulmonary diseases.
“We have several, near-term milestones in our mid- to late-stage
pipeline that could transform our business from a development-stage
organization to a fully-integrated, commercial biopharmaceutical
company,” said Habib Dable, Chief Executive Officer of
Acceleron. “With the opportunity to launch and co-promote
luspatercept in North America, and the continued advancement of our
neuromuscular candidate as well as our recent entry into pulmonary
disease, we are positioned to bring potentially life-changing new
treatments to patients and drive value for our shareholders. We
expect to report top-line Phase 3 results of luspatercept in
myelodysplastic syndromes and beta-thalassemia alongside our
collaboration partner Celgene, in mid-2018. ACE-083 continues to
advance through multiple Phase 2 clinical trials, and ACE-2494, the
second asset in our neuromuscular franchise, is expected to
initiate a clinical trial later this year. The recent announcement
of our plan to develop sotatercept as a Phase 2 therapeutic
candidate for the potential treatment of pulmonary arterial
hypertension is a tremendous opportunity for us, given that it
launches our therapeutic focus in pulmonary disease and enhances
our commitment to develop new therapies that could transform
patients’ lives.”
Key R&D Day
Highlights:
Hematology
- Luspatercept
- Significant market expansion efforts
across multiple new indications are being pursued by Acceleron and
Celgene in addition to the potential blockbuster market opportunity
in initial MEDALIST and BELIEVE Phase 3 indications
- A third Phase 3 trial, also known as
the COMMANDS trial, is expected to begin in early 2018
- The COMMANDS trial will evaluate
luspatercept versus erythropoiesis-stimulating agent (ESA)
treatment in first-line, lower-risk MDS, and include patients
regardless of ring sideroblast (RS) status
- A Phase 2 trial in
non-transfusion-dependent (NTD) beta-thalassemia patients, also
known as the BEYOND trial, is expected to begin later this year,
and the Phase 2 trial in myelofibrosis is underway
Neuromuscular
- ACE-083 and ACE-2494
- ACE-083 and ACE-2494 utilize the
Company’s “Myostatin+” approach to increase muscle strength and
function by inhibiting multiple ligands of the TGF-beta
superfamily
- ACE-083, a targeted muscle agent being
developed for the treatment of facioscapulohumeral dystrophy (FSHD)
and Charcot-Marie-Tooth (CMT) disease, has shown increases in
muscle mass of 9% to 15% in healthy volunteers
- Company expects Phase 2 FSHD part 1
preliminary results from cohort 1 to be available in late 2017
- ACE-2494, a systemic muscle agent, has
demonstrated preclinical activity across multiple neuromuscular
diseases
Pulmonary
- Sotatercept
- Acceleron gains rights for pulmonary
hypertension indications from Celgene
- Preclinical results show potential for
sotatercept to be a first-in-class disease-modifying therapy that
addresses fundamental molecular causes of disease in pulmonary
arterial hypertension (PAH)
- Company expects to initiate a Phase 2
trial in PAH during the first half of 2018
- ACE-1334
- Multiple, ongoing preclinical studies
in pulmonary disease
About Acceleron
Acceleron is a biopharmaceutical leader in TGF-beta science,
focused on the discovery and development of innovative therapeutics
to treat patients with serious and rare diseases. Its pioneering
research and protein engineering platform engages the target-rich
TGF-beta superfamily and its ability to regulate cellular growth
and repair.
Under a global partnership with Celgene, Acceleron is in Phase 3
development with luspatercept, a potential first-in-class chronic
anemia therapy for the treatment of rare blood diseases. The
Company is also advancing a 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. Acceleron has ongoing preclinical research
efforts targeting additional indications in these three disease
areas where there is significant unmet medical need.
For more information, please
visit www.acceleronpharma.com/. Follow Acceleron on Social
Media: @AcceleronPharma and LinkedIn.
Cautionary Note on 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," "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/20170919006177/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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