Scholar Rock Announces Issuance of U.S. Patent Providing Composition of Matter Protection for SRK-015
August 27 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
that the United States Patent Office (USPTO) issued U.S. Patent No.
10,751,413 providing product protection for SRK-015, including
composition of matter and methods of use, with an expiry of January
2037.
“We are at the forefront in the development of antibodies that
target the latent form of many growth factors. This composition of
matter patent further protects SRK-015, which targets the latent
form of myostatin and is being evaluated in the TOPAZ Phase 2 trial
for patients with Spinal Muscular Atrophy,” said Tony Kingsley,
President and CEO of Scholar Rock. “We continue to build and
strengthen our patent portfolio with patents that specifically
protect our product candidates, SRK-015 and SRK-181, as well as a
broader family of platform patents directed to our unique approach
to targeting the TGFβ superfamily of growth factors more
generally.”
The composition of matter patent is directed to the full-length
amino acid sequence of SRK-015 that specifically binds to
pro/latent myostatin while avoiding binding to mature myostatin and
related growth factors, such as GDF11 and Activin A. The patent
also covers methods of treating myopathy, muscle atrophy and
metabolic disorders. The ongoing TOPAZ Phase 2 trial is evaluating
SRK-015’s potential in improving motor function in patients with
Type 2 and Type 3 Spinal Muscular Atrophy. A 6-month interim
readout is anticipated in the fourth quarter of 2020 with top-line
data for the 12-month treatment period expected in the first half
of 2021.
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 Rare Pediatric Disease (RPD) designation, 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 approach to
targeting 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 its growth, strategy,
progress and timing of its clinical trials for SRK-015, SRK-181,
and other product candidates and development timing, the potential
of its proprietary platform, and its intellectual property
protection. 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, the data
generated from Scholar Rock’s nonclinical and preclinical studies
and clinical trials, competition from third parties that are
developing products for similar uses, Scholar Rock’s ability to
obtain, maintain and protect its intellectual property, the success
of Scholar Rock’s current and potential future collaborations,
including its collaboration with Gilead, Scholar Rock’s dependence
on third parties for development and manufacture of product
candidates including to supply any clinical trials, Scholar Rock’s
ability to manage expenses and to obtain additional funding when
needed to support its business activities and establish and
maintain strategic business alliances and new business initiatives,
and the impacts of public health pandemics such as COVID-19 on
business operations and expectations, as well as those risks more
fully discussed in the section entitled "Risk Factors" in Scholar
Rock’s Quarterly Report on Form 10-Q for the quarter ended June 30,
2020, 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/20200827005172/en/
Scholar Rock: Investors/Media Catherine Hu
chu@scholarrock.com 917-601-1649
Media: The Yates Network Kathryn Morris
kathryn@theyatesnetwork.com 914-204-6412
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