Scholar Rock Presents Data for SRK-015 at the Muscular Dystrophy Association Clinical and Scientific Conference
March 24 2020 - 6:30AM
Business Wire
Scholar Rock (NASDAQ: SRRK), a clinical-stage
biopharmaceutical company focused on the treatment of serious
diseases in which protein growth factors play a fundamental role,
today announced an oral presentation on SRK-015, a highly specific
inhibitor of the activation of latent myostatin, at the Muscular
Dystrophy Association (MDA) Clinical & Scientific
Conference. The presentation will highlight key preclinical
and Phase 1 healthy volunteer clinical data that supported the
initiation of the TOPAZ Phase 2 proof-of-concept trial evaluating
SRK-015 for the treatment of patients with Type 2 and Type 3 Spinal
Muscular Atrophy (SMA).
The details for the SRK-015 presentation at the MDA conference
are as follows:
- Title: Clinical Development of SRK-015, a Fully Human
Anti-pro Myostatin Monoclonal Antibody, for the Treatment of Later
Onset Spinal Muscular Atrophy
- Virtual Clinical Trial Session: Tuesday, March 24,
2020 from 11:00am – 4:00pm ET (link to the virtual session provided
by MDA to all registered attendees)
About SRK-015
SRK-015 is a selective inhibitor of the activation of myostatin
and is an investigational product candidate for the treatment of
patients with spinal muscular atrophy (SMA). Myostatin, a
member of the TGFβ superfamily of growth factors, is expressed
primarily by skeletal muscle cells and the absence of its gene is
associated with an increase in muscle mass and strength in multiple
animal species. Scholar Rock believes the inhibition of the
activation of myostatin with SRK-015 may promote a clinically
meaningful increase in muscle strength. A Phase 2 clinical
trial in patients with Type 2 and Type 3 SMA is ongoing. The
U.S. Food and Drug Administration (FDA) has granted Orphan Drug
Designation (ODD), and the European Commission (EC) has granted
Orphan Medicinal Product Designation, to SRK-015 for the treatment
of SMA. The effectiveness and safety of SRK-015 have not been
established and SRK-015 has not been approved for any use by the
FDA or any other regulatory agency.
About Scholar Rock Scholar Rock is a
clinical-stage biopharmaceutical company focused on the discovery
and development of innovative medicines for the treatment of
serious diseases in which signaling by protein growth factors plays
a fundamental role. Scholar Rock is creating a
pipeline of novel product candidates with the potential to
transform the lives of patients suffering from a wide range of
serious diseases, including neuromuscular disorders, cancer,
fibrosis and anemia. Scholar Rock’s newly elucidated
understanding of the molecular mechanisms of growth factor
activation enabled it to develop a proprietary
platform for the discovery and development of monoclonal
antibodies that locally and selectively target these signaling
proteins at the cellular level. By developing product
candidates that act in the disease microenvironment, the Company
intends to avoid the historical challenges associated with
inhibiting growth factors for therapeutic effect. Scholar
Rock believes its focus on biologically validated growth factors
may facilitate a more efficient development path. For more
information, please visit www.ScholarRock.com or
follow Scholar Rock on Twitter (@ScholarRock) and
LinkedIn (https://www.linkedin.com/company/scholar-rock/).
Scholar Rock® is a registered trademark of Scholar Rock,
Inc.
Forward-Looking Statements
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including, but not limited to, statements regarding Scholar
Rock’s future expectations, plans and prospects, including without
limitation, Scholar Rock’s expectations regarding the timing of its
clinical trials for SRK-015; the potential of SRK-015 to address
certain patient unmet needs; and the ability of any product
candidate to perform in humans in a manner consistent with
nonclinical or preclinical study data. The use of words such as
“may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,”
“believe,” “estimate,” “project,” “intend,” “future,” “potential,”
or “continue,” and other similar expressions are intended to
identify such forward-looking statements. All such forward-looking
statements are based on management's current expectations of future
events and are subject to a number of risks and uncertainties that
could cause actual results to differ materially and adversely from
those set forth in or implied by such forward-looking statements.
These risks and uncertainties include Scholar Rock’s ability to
provide the financial support, resources and expertise necessary to
identify and develop product candidates on the expected timeline;
preclinical data and results may not be predictive of clinical
results; Scholar Rock’s dependence on third parties for development
and manufacture of product candidates including to supply any
clinical trials; and those risks more fully discussed in the
section entitled "Risk Factors" in Scholar Rock’s Annual Report on
Form 10-K for the year ended December 31, 2019, as well as
discussions of potential risks, uncertainties, and other important
factors in Scholar Rock’s subsequent filings with the Securities
and Exchange Commission. Any forward-looking statements
represent Scholar Rock’s views only as of today and should not be
relied upon as representing its views as of any subsequent date.
All information in this press release is as of the date of the
release, and Scholar Rock undertakes no duty to update this
information unless required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20200324005193/en/
Scholar Rock Contact: Investors/Media Catherine Hu
chu@scholarrock.com 917-601-1649
Media Contact: The Yates Network Kathryn Morris
kathryn@theyatesnetwork.com 914-204-6412
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