LA JOLLA, Calif., Aug. 16, 2021 /PRNewswire/ -- Avidity
Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company
committed to delivering a new class of RNA therapeutics called
Antibody Oligonucleotide Conjugates (AOCs™), today announced its
collaboration with the Facioscapulohumeral Muscular Dystrophy
(FSHD) Clinical Trial Research Network (FSHD CTRN) to support a
natural history study for people living with FSHD called the Motor
Outcomes to Validate Evaluations Plus (MOVE+) Study.
MOVE+ is a sub-study of the ongoing natural history study called
Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD). Avidity
is sponsoring 100 participants to enroll in the MOVE+ sub-study in
the US. The goal of MOVE+ is to enhance the community's
understanding of how to utilize whole-body MRI and other tools to
identify specific biomarkers for FSHD that can accelerate and
support future clinical trial design.
"We are committed to support this critically important work and
the FSHD community as we work in concert to further understand this
devastating disease," said Sarah
Boyce, president and CEO of Avidity. "The MOVE+ study will
provide important insight into the predictive nature of MRI
biomarkers and inform our clinical development program for
FSHD."
"Because FSHD is a complex disease that manifests intermittently
in different muscles, it is challenging to design clinical studies
that have impactful endpoints and that can enroll participants with
active disease," said Jeffrey
Statland, M.D., professor, Department of Neurology,
University of Kansas Medical Center.
"By expanding our knowledge of biomarkers and their relation to
disease progression, MOVE and MOVE+ could have a direct and
immediate impact on patient care and inform future research and
development of new therapies for people living with
FSHD."
The FSHD CTRN is a group of 18 academic research centers across
the United States and Europe, with expertise in FSHD clinical
research or in conducting neuromuscular clinical trials. It was
formed with early support and encouragement from the FSHD Society,
the Muscular Dystrophy Association, Friends of FSH Research as well
as other stakeholders in the patient community. FSHD CTRN helps to
close gaps in trial readiness and provides a network of sites with
centralized streamlined regulatory process, common expertise in
FSHD, and an engaged patient population ready to participate in
high quality clinical trials.
Mark Stone, Chief Executive
Officer of the FSHD Society stated, "It is so encouraging to see
such active engagement and collaboration from the FSHD CTRN, the
patient and advocacy community and industry leaders like Avidity.
The launch of the MOVE+ study is an important milestone as we
advance toward our shared goal of delivering meaningful treatments
to counteract the effects of this devastating disease."
About the FSHD Society
The FSHD Society is the world's largest research-focused patient
advocacy organization for facioscapulohumeral muscular dystrophy
(FSHD), one of the most prevalent forms of muscular dystrophy. The
Society has catalyzed major advancements and is accelerating the
development of treatments and a cure to end the pain, disability,
and suffering endured by one million people worldwide who live with
FSHD. The FSHD Society has transformed the landscape for FSHD
research and is committed to making sure that no one faces this
disease alone. The Society offers a community of support, news, and
information through its website
at https://www.fshdsociety.org.
About FSHD Clinical Trial Research Network
The Facioscapulohumeral Muscular Dystrophy Clinical Trial
Research Network (FSHD CTRN) is a consortium of 18 academic
research centers (12 in the United
States, five in continental Europe and one in the United Kingdom) with expertise in FSHD
clinical research, or in conducting neuromuscular clinical trials.
These centers leverage existing clinical trials infrastructure:
including clinical investigators, research coordinators, study
evaluators, and institutional resources like Clinical and
Translational Science Awards (CTSAs) and local Research Institutes
for clinical trial budget and contracting, and Clinical Research
Centers, which provide subsidized clinical research space and
facilities. The FSHD CTRN helps close gaps in trial readiness, and
also provides a network of sites with a centralized streamlined
regulatory process, specific, common expertise in FSHD, and an
engaged patient population ready to conduct efficient, high quality
clinical trials. Click here for more information on the FSHD
CTRN.
About Avidity Biosciences
Avidity Biosciences, Inc.'s mission is to profoundly improve
people's lives by delivering a new class of RNA therapeutics -
Antibody Oligonucleotide Conjugates (AOCs™). Avidity's
proprietary AOCs are designed to combine the specificity of
monoclonal antibodies with the precision of oligonucleotide
therapies to target the root cause of diseases previously
untreatable with RNA therapeutics. Avidity's lead product
candidate, AOC 1001, is designed to treat myotonic dystrophy type 1
(DM1). The FDA has cleared Avidity to proceed with the Phase 1/2
MARINA™ trial of AOC 1001 in adults with DM1. Its
advancing and expanding pipeline also includes programs in
facioscapulohumeral muscular dystrophy (FSHD), Duchenne Muscular
Dystrophy (DMD), muscle atrophy and Pompe disease. The company is
planning for AOC 1044, the lead of three programs for the treatment
of DMD, and its AOC FSHD program to enter the clinic in 2022.
Avidity is also broadening the reach of AOCs beyond muscle tissues
through both internal discovery efforts and key partnerships as the
company continues to deliver on the RNA revolution. Avidity is
headquartered in La Jolla, CA. For
more information about our science, pipeline and people,
please visit www.aviditybiosciences.com and engage with
us on LinkedIn and Twitter.
Forward-Looking Statements
Avidity cautions readers that statements contained in this press
release regarding matters that are not historical facts are
forward-looking statements. These statements are based on our
current beliefs and expectations. Such forward-looking statements
include, but are not limited to, statements regarding: the
potential of FSHD natural history studies including the MOVE and
MOVE+ studies to impact clinical development. The inclusion of
forward-looking statements should not be regarded as a
representation by Avidity that any of our plans will be achieved.
Actual results may differ from those set forth in this press
release due to the risks and uncertainties inherent in our
business, including, without limitation: we are early in our
development efforts and our FSHD development programs are in the
preclinical or discovery stage; our approach to the discovery and
development of product candidates for the treatment of FSHD based
on our AOC platform is unproven, and we do not know whether we will
be able to develop any products of commercial value; potential
delays in the commencement, enrollment and completion of clinical
trials; disruption to our operations from the COVID-19
pandemic; the success of our preclinical studies and clinical
trials for our product candidates; the results of preclinical
studies and early clinical trials are not necessarily predictive of
future results; our dependence on third parties in connection with
preclinical testing and product manufacturing; unexpected adverse
side effects or inadequate efficacy of our product candidates that
may limit their development, regulatory approval and/or
commercialization, or may result in recalls or product liability
claims; regulatory developments in the United States and
foreign countries, including acceptance of INDs and similar foreign
regulatory filings and our proposed design of future clinical
trials; risks related to integration of new personnel; and other
risks described in our prior press releases and in our filings with
the Securities and Exchange Commission (SEC). Avidity cautions
readers not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof, and we
undertake no obligation to update such statements to reflect events
that occur or circumstances that exist after the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement, which is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995.
Company & Investors Contact:
Kath Gallagher
kath.gallagher@aviditybio.com
858-401-7900 ext 550
Media Contact:
Cherise
Adkins
cadkins@spectrumscience.com
(301) 267-4161
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SOURCE Avidity Biosciences, Inc.