Scholar Rock Announces Issuance of U.S. Patent Protecting Add-On or Combination Therapy with a Myostatin Inhibitor for the Tr...
March 17 2021 - 3:05PM
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.
10,946,036 with an expiry of June 2037. The claims of the patent
broadly cover both add-on and combination therapy with a myostatin
inhibitor and a neuronal corrector therapy (such as SMN upregulator
therapy) for the treatment of Spinal Muscular Atrophy (SMA).
“We are delighted to have been granted this unique patent that
further protects our myostatin approach to improving motor function
for patients with SMA and we look forward to the top-line read-out
from the apitegromab TOPAZ Phase 2 trial next quarter, which will
provide additional insights on its potential to help patients with
Type 2 and Type 3 SMA,” said Tony Kingsley, President and CEO of
Scholar Rock. “In parallel with preclinical and clinical
advancements, we will continue to build and strengthen our family
of patents protecting our product candidates and our scientific
platform.”
The broad claims of this therapeutic method patent are not
limited to apitegromab or to add-on or combination treatment with
any specific SMN upregulator therapy. Similar claims have also been
granted in Japan (JP Patent No. 6823167) and in Europe (EP
3368069B1).
About SMA
Spinal muscular atrophy (SMA) is a rare, and often fatal,
genetic disorder that typically manifests in young children. An
estimated 30,000 to 35,000 patients are afflicted with SMA in the
United States and Europe. It is characterized by the loss of motor
neurons, atrophy of the voluntary muscles of the limbs and trunk
and progressive muscle weakness. The underlying pathology of SMA is
caused by insufficient production of the SMN (survival of motor
neuron) protein, essential for the survival of motor neurons, and
is encoded by two genes, SMN1 and SMN2. While there has been
progress in the development of therapeutics that address the
underlying SMA genetic defect, there continues to be a high unmet
need for therapeutics that directly address muscle atrophy.
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 the
potential of apitegromab, 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 apitegromab, 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
the possibility that data from the TOPAZ final analysis will be
inconsistent with the data observed in the interim analysis,
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, 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 including its TOPAZ clinical trial, as well as 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, 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/20210317005726/en/
Scholar Rock Contacts: Investor Contact: Catherine
Hu chu@scholarrock.com Media Contact: Ariane Lovell Finn
Partners ariane.lovell@finnpartners.com 917-565-2204
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