Global Neurology Leaders to Support Development
of a Potentially Restorative Treatment for MS as Program Advances
Toward 2023 Regulatory Filing
Company also Expands Regenerative Medicine
Advisory Board with Addition of Nobel Laureate and Cell Biologist
Dr. James Rothman
Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage
regenerative medicine company focused on developing therapeutics to
activate a person’s innate potential to restore function, today
announced that it has established a Clinical Advisory Board to help
guide its remyelination in multiple sclerosis (MS) program.
Comprised of leading experts from across the neurosciences, the
Clinical Advisory Board will support clinical development and
translation efforts as the Company advances its small molecule
therapeutic candidate through human studies. The Company plans a
regulatory filing for its remyelination program in the second half
of 2023.
The Company also announced today that James Rothman, Ph.D., will
join its Progenitor Cell Activation (PCA) Regenerative Medicine
Advisory Board. Dr. Rothman is the Sterling Professor of Cell
Biology at Yale University, Chairman of the Yale School of
Medicine’s Department of Cell Biology and the Director and founder
of the Nanobiology Institute. One of the world’s leading
biochemists and cell biologists, he was awarded the Nobel Prize in
Medicine in 2013 for his discovery of machinery regulating vesicle
traffic, or the transfer of materials within cells, providing a
framework to understand key physiological processes such as
communication between nerve cells in the brain.
“While a number of approved drugs are highly effective in
preventing new inflammatory lesions, stopping gradual
neurodegeneration and gradual clinical worsening remain the
greatest areas of unmet need,” said Richard Rudick, Ph.D., the
former Chief Clinical Research Officer at Cleveland Clinic, Vice
Chairman for Research and Development in the Clinic’s Neurological
Institute, and a member of Frequency’s Remyelination Clinical
Advisory Board. “Supported by impressive preclinical data generated
to date, Frequency has an opportunity to develop an entirely new
therapy to address remyelination, and potentially provide those
with MS with a first-in-class medicine with the hope of repairing
damage caused by this challenging disease.”
“We are grateful to have the opportunity to work with
world-class leaders in neurology and multiple sclerosis on our
newly formed Clinical Advisory Board. Their expertise developing
transformative medicines for serious neurological diseases will be
invaluable as we advance our remyelination program into clinical
studies,” said Christopher Loose, Ph.D., Frequency’s chief
scientific officer. “We’re also honored to announce the addition of
Dr. Rothman to our Remyelination Advisory Board. Dr. Rothman is
among the preeminent cell biologists in the world and his
scientific insights will help inform our efforts for optimally
applying our regenerative medicine technology for the treatment of
human disease.”
Clinical Advisory Board Members
Laura J. Balcer, M.D., M.S.C.E., Professor of Neurology,
Population Health and Epidemiology, and Vice Chair, Department of
Neurology at the NYU Grossman School of Medicine. She co-leads
national collaborative clinical and research efforts in the
neuro-ophthalmology of MS, concussion and other neurologic
disorders. Her primary research focus has been on the
identification and development of clinical visual outcome measures
for MS trials and on determining which clinical tests best identify
visual dysfunction in patients with MS. In 2015, Dr. Balcer and her
team received the Barancik Prize for Innovation in MS Research from
the National MS Society. As a mentor to more than 100 research
trainees, Dr. Balcer received the Distinguished Teacher Award from
the NYU Grossman School of Medicine in 2021.
Alasdair Coles, Ph.D., Professor of Neuroimmunology at
the University of Cambridge. Dr. Coles was closely involved in the
development of alemtuzumab (Campath-1H), a humanized monoclonal
antibody as a treatment for MS. Alemtuzumab has received its
European license and was approved by the FDA and NICE. He has also
led trials of a novel remyelinating therapy in MS and of
immunotherapy in autoimmune psychosis. Dr. Coles treats people with
MS, general neurological problems and those with inflammatory
diseases of the brain. He was Chair of the MS Advisory Group of the
Association of British Neurologists, Chair of Cure Parkinson’s
research committee and chaired the group that drew up the latest
NHS England MS Treatment Algorithm.
Steven Galetta, M.D., Philip K. Moskowitz, MD, Professor
of Neurology and Ophthalmology, and Chair of the Department of
Neurology at the NYU Grossman School of Medicine since 2012. Dr.
Galetta has been involved in various capacities in a large number
of clinical trials and has over 400 publications concerning
clinical, radiologic and research aspects of MS, sports related
concussion and neuro-ophthalmology. He is co-author of the
textbook, Neuro-ophthalmology: Diagnosis and Management, 3rd
edition. In 1998, Dr. Galetta was awarded the Louis Duhring
Outstanding Clinical Specialist Award from the University of
Pennsylvania, and has been named NYU Langone’s Master Clinician. In
2018, The American Academy of Neurology named him the AB Baker
Award recipient for his lifetime achievement in neurological
education.
Richard Rudick, M.D., independent consultant having spent
decades as an industry and academic leader, and in clinical
practice. Most recently he was Vice President, Development Science,
and Director of the Value Based Medicine MS Innovation Hub at
Biogen. Dr. Rudick’s research has focused on experimental
therapeutics, including innovative approaches to measuring
immunologic, clinical, and imaging features of the disease for use
in clinical research and practice. He played key roles in
development of IFNß-1a (Avonex) and natalizumab (Tysabri) for
relapsing forms of MS. For 30 years, his clinical practice focused
on diagnosis and management of MS patients. He directed the Mellen
Center at the Cleveland Clinic where he also had roles as the Chief
Clinical Research Officer and Vice Chairman for Research and
Development in the Neurological Institute.
About Multiple Sclerosis Multiple sclerosis (MS) is a
neurological disease that affects nearly 1 million people in the
United States. The disabling condition is caused by an immune
attack on myelin, the insulating material that coats and protects
axons in the brain. As myelin breaks down, patients with MS
experience a variety of symptoms ranging from sensory and motor
deficits (particularly sight and touch) to muscle weakness and
walking difficulties, cognitive challenges and fatigue. Just as the
company aims to regenerate the structures necessary for hearing,
Frequency’s MS program aims to develop novel, first in class
small-molecule therapeutics to activate oligodendrocyte progenitor
cells to regenerate oligodendrocytes and myelin lost to MS.
About Frequency Therapeutics Frequency Therapeutics is
leading a new category in regenerative medicine that aims to
restore human function – first in hearing loss and then in multiple
sclerosis – by developing therapeutics that activate a person’s
innate regenerative potential within the body through the
activation of progenitor cells. Frequency’s hearing research
focuses on cochlear restoration and auditory repair, and its lead
asset, FX-322, is a small-molecule combination product candidate
that is the first to show statistically significant and clinically
meaningful hearing improvements in clinical trials for
sensorineural hearing loss. Frequency is also leveraging its
Progenitor Cell Activation (PCA) approach to activate existing
precursor cells in MS patients to remyelinate axons and restore
signal transmission. The company has identified and validated a
novel target, where a clear and compelling regenerative signal in
pre-clinical studies has been observed.
Headquartered in Lexington, Mass., Frequency has an ex-U.S.
license and collaboration agreement with Astellas Pharma Inc. for
FX-322, as well as additional collaboration and licensing
agreements with academic and nonprofit research organizations
including Massachusetts Eye and Ear, Mass General Brigham, the
Massachusetts Institute of Technology, and the Scripps Research
Institute.
For more information, visit www.frequencytx.com and follow
Frequency on Twitter @Frequencytx.
Forward-Looking Statements This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements contained
in this press release that do not relate to matters of historical
fact should be considered forward-looking statements, including
without limitation statements regarding the timing of the
remyelination in MS program, the treatment potential of FX-322 and
the remyelination in MS program, estimates of the size of the MS
population, and the potential application of the progenitor cell
activation (PCA) platform to other diseases.
These forward-looking statements are based on management’s
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause actual results, performance
or achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements, including, but not limited to, the
following: the impact of COVID-19 on the Company’s ongoing and
planned clinical trials, research and development and manufacturing
activities, the Company’s business and financial markets; the
Company has incurred and will continue to incur significant losses
and is not and may never be profitable; the Company’s need for
additional funding to complete development and commercialization of
any product candidate; the Company’s dependence on the development
of FX-322; the unproven approach of the PCA platform and the
inability to identify additional potential product candidates; the
lengthy, expensive and uncertain process of clinical drug
development and regulatory approval; the Company’s limited
experience successfully obtaining marketing approval for and
commercializing product candidates; the results of earlier clinical
trials not being indicative of the results from later clinical
trials; differences between preliminary or interim data and final
data; adverse events or undesirable side effects; disruptions at
the FDA and other regulatory agencies; failure to identify
additional product candidates; new or changed legislation; failure
to maintain Fast Track designation for FX-322 and such designation
failing to result in faster development or regulatory review or
approval; ability to seek and receive Breakthrough Therapy
designation for FX-322; the Company’s ability to enroll and retain
patients in clinical trials; costly and damaging litigation,
including related to product liability or intellectual property or
brought by stockholders; dependence on Astellas Pharma Inc. for the
development and commercialization of FX-322 outside of the United
States; misconduct by employees or independent contractors;
reliance on third parties, including to conduct clinical trials and
manufacture product candidates; compliance with changing laws and
regulations, including healthcare and environmental, health, data
privacy and safety laws and regulations; failure to obtain,
maintain and enforce protection of patents and other intellectual
property rights covering product candidates; security breaches or
failure to protect private personal information; attracting and
retaining key personnel; and the Company’s ability to manage
growth.
These and other important factors discussed under the caption
“Risk factors” in the Company’s Form 10-Q filed with the Securities
and Exchange Commission (SEC) on November 8, 2022 and its other
reports filed with the SEC could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release. Any such forward-looking statements
represent management’s estimates as of the date of this press
release. While the Company may elect to update such forward-looking
statements at some point in the future, it disclaims any obligation
to do so, even if subsequent events cause its views to change.
These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the
date of this press release.
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version on businesswire.com: https://www.businesswire.com/news/home/20221219005117/en/
Investor: Carlo Tanzi, Ph.D. Kendall Investor Relations
ctanzi@kendallir.com 617-914-0008
Media: Frequency Therapeutics Email: media@frequencytx.com
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