Management and Leading KOLs will Provide
Detailed Review of Completed FX-322 Clinical Data in Subjects with
Sensorineural Hearing Loss (SNHL), Supporting Design of FX-322-208
Phase 2b Study
New Hearing Restoration Program Advances Toward
Clinical Studies Providing Broader Cochlear Exposure with the
Potential to Address Expanded SNHL Patient Populations
Novel Remyelinating Agent Against a New
Biological Target Being Advanced for Multiple Sclerosis (MS); In
Vivo Data Show Substantially Greater Activity than Biologic or
Small Molecule Comparators
Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage
regenerative medicine company focused on developing therapeutics to
activate a person’s innate regenerative potential to restore
function, today will host a virtual R&D event. The webcast can
be accessed here.
“We look forward to highlighting the extensive data supporting
our Phase 2b study (FX-322-208) in patients with sensorineural
hearing loss (SNHL), where we have seen clear clinical improvements
in speech perception in patient groups that include millions of
individuals in the US alone. We have alignment with the FDA on
speech perception as the primary efficacy endpoint and will detail
the importance of this measure for patients. Our Phase 2b study is
enrolling subjects who we believe fit squarely in the range where
we have seen clinically meaningful hearing improvements, and we
will detail the design of this study,” said David L. Lucchino,
Frequency’s Chief Executive Officer.
Mr. Lucchino continued: “We will also unveil two new research
programs that demonstrate the potential of our progenitor cell
activation (PCA) approach. First, we will introduce FX-345, a new
hearing restoration candidate designed for greater distribution
through the cochlea, potentially enabling the treatment of expanded
SNHL patient populations. We also have a highly promising novel
therapeutic approach for multiple sclerosis, remyelinating agents
that demonstrate a level of activity that far exceeds alternatives
that have been developed to date.”
Event Highlights:
FX-322
- Clinical data review from four completed FX-322 clinical
studies, including 169 subjects with a range of hearing loss
severities and SNHL etiologies (sudden, noise-induced,
age-related).
- Analysis of statistically significant and clinically meaningful
patient responses following a single FX-322 administration,
establishing the range of severity and etiologies that will be
explored in the upcoming FX-322-208 study.
- Review of design of ongoing FX-322-208 study, including use of
multiple lead-in hearing measures implemented to reduce study bias
and baseline variability.
- Alignment with the U.S. Food and Drug Administration around
speech perception measures as a primary efficacy endpoint and the
importance of speech perception as the key unmet need for
individuals with SNHL.
FX-345
- Introduction of new SNHL investigational therapeutic program,
including a more potent GSK3 inhibitor designed to achieve broader
exposure of the cochlea.
- Preclinical pharmacokinetic measures and human modeling data,
indicating that therapeutically active FX-345 drug levels will be
reached in areas of the cochlea corresponding to a wider range of
hearing frequencies.
- Potential to benefit an expanded SNHL patient population.
- IND anticipated in Q2 2022.
Remyelination in Multiple
Sclerosis
- Identified novel therapeutic target that drives oligodendrocyte
progenitor cell differentiation and myelination.
- FREQ-162, preclinical stage lead compound, induces
substantially more remyelination than published, comparator
approaches.
- FREQ-162 being advanced in preclinical safety studies toward
the initiation of clinical development.
Event Details and Agenda:
The webcast event will be held today, November 9, 2021, from 8
a.m. to 10 a.m. EST, and will include a live Q&A session.
Presentations by Frequency management and academic subject matter
experts will include:
David L. Lucchino, Chief Executive Officer: Strategic
Company overview
Robert S. Langer, ScD, Frequency Therapeutics co-founder and
MIT Institute Professor: Pioneering a new category in
regenerative medicine
Carl LeBel, PhD, Chief Development Officer: Key learnings
from FX-322 hearing restoration program and clinical development
path
Sumit Dhar, PhD, Hugh Knowles Professor of Hearing Science
and Associate Provost for Faculty at Northwestern University:
Cochlear pathology and the impact of high frequencies on speech
perception
Kevin Franck, PhD, SVP, Strategic Marketing and New Product
Planning: FX-322 clinical data and real-world impact of speech
perception improvements
Steven D. Targum, MD, Independent Consultant, Scientific
Director, Signant Health: Best-practice approaches for
addressing placebo response in clinical trials
Christopher Loose, PhD, Chief Scientific Officer: New
regenerative programs from continued progenitor cell activation
(PCA) research, and a new hearing program for sensory hair cell
regeneration
Sanjay Magavi, PhD, VP, Myelination Research:
Remyelination for multiple sclerosis: Discovery of a novel target
with exceptional in vivo activity
To register for the event, please visit:
https://investors.frequencytx.com/2021_Virtual_R-D_Event. An
archived replay will be available for at least 30 days following
the presentation.
About Frequency Therapeutics
Frequency Therapeutics is leading a new category in regenerative
medicine that aims to restore function – first in hearing loss and
then in multiple sclerosis (MS) – 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 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 following early
restorative signals in MS to develop medicines with the same
underlying regenerative science being brought to hearing loss.
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, the Scripps Research
Institute and Cambridge Enterprises Limited. 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 design of the new Phase 2 trial of FX-322, including
the type of SNHL that the enrolled patients will have and the
ability of design features to reduce bias, the interpretation and
implications of the results and learnings of other FX-322 clinical
studies, the acceptance by the FDA of particular endpoints in the
Company’s trials, the treatment potential of FX-322, FX-345, and
the novel approach for remyelination in multiple sclerosis, the
timing and progress of the FX-345 and remyelination programs, the
speakers, timing of and topics to be discussed during the R&D
event, the ability of our technology platform to provide patient
benefit, the ability to continue to develop our Progenitor Cell
Activation (PCA) platform and identify additional product
candidates, and the potential application of the 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 relocation of the Company’s offices and laboratory
facilities, 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; the lengthy,
expensive and uncertain process of clinical drug development and
regulatory approval; 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; 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 laws and
regulations, including healthcare and environmental, health, and
safety laws and regulations; failure to obtain, maintain and
enforce protection of patents and other intellectual property;
security breaches or failure to protect private personal
information; attracting and retaining key personnel; and 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 August 12, 2021 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211109005328/en/
Investor Contact: Carlo Tanzi, Ph.D. Kendall Investor Relations
ctanzi@kendallir.com 617-914-0008
Media Contact: Suzanne Day Frequency Therapeutics
sday@frequencytx.com 781-496-2211
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