Acceleron Announces Publication of ACE-083 Phase 1 Trial Results in Muscle & Nerve
28 Febrero 2018 - 6:04AM
Business Wire
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 that the journal Muscle & Nerve has published the
final results from the Phase 1 trial of ACE-083, the Company's
locally acting, “Myostatin+”, muscle agent. ACE-083 treatment
generated dose-dependent mean total muscle volume increases of up
to 14.5% in the rectus femoris (RF) and 8.9% in the tibialis
anterior (TA) three weeks after the last dose.
“These unprecedented increases in total muscle volume produced
in the Phase 1 trial of ACE-083 were critical in leading us to
rapidly advance into two Phase 2 trials in two distinct diseases of
focal muscle weakness, and we are thrilled that the Muscle &
Nerve journal has selected this study for publication,” said
Matthew Sherman, M.D., Chief Medical Officer of Acceleron. “The
significant level of activity observed with ACE-083 in this Phase 1
trial was recently confirmed in Part 1 of the facioscapulohumeral
dystrophy (FSHD) Phase 2 trial, with preliminary results generating
mean total muscle volume increases of over 12% in the two muscles
evaluated. We believe ACE-083 could have a significant impact in
increasing muscle mass, strength, and function in patients with
neuromuscular disorders.”
The article, entitled “Locally Acting ACE-083 Increases Muscle
Volume in Healthy Volunteers” is now available online and will be
published in a future print issue of Muscle & Nerve. The Phase
1 trial was a randomized, double-blind, placebo-controlled,
dose-ranging study in healthy volunteers. The key objectives of the
trial were safety and tolerability, as well as assessing changes in
total muscle volume of the treated muscles via magnetic resonance
imaging (MRI) of the RF and TA muscles.
ACE-083 is currently being evaluated in two Phase 2 trials in
FSHD and Charcot-Marie-Tooth (CMT) disease. The Company recently
announced preliminary results from Part 1 of the FSHD trial with
mean total volume increases of over 12% in the tibialis anterior
and biceps brachii muscle cohorts. The final Part 1 results from
both Phase 2 trials are expected in the second half of 2018. Part 2
of the FSHD trial is expected to be initiated in the second quarter
of 2018 with results expected in the second half of 2019. Part
2 of the CMT trial is expected to be initiated before the end of
2018.
Presentations outlining the Phase 1 results included in the
publication are available online under the science page on the
Company’s website at www.acceleronpharma.com.
About ACE-083
ACE-083 is a therapeutic candidate, based on the
naturally-occurring protein follistatin, which utilizes the
"Myostatin+" approach to inhibit multiple TGF-beta ligands. It is
designed to have a concentrated effect along targeted muscles to
maximize growth and strength selectively in the muscles into which
the drug is administered. Acceleron is developing ACE-083 for
diseases such as facioscapulohumeral dystrophy (FSHD) and
Charcot-Marie-Tooth (CMT) disease, in which improved muscle
strength in target muscles may provide a clinical benefit and
enhance quality of life.
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.
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," “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/20180228005689/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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