In Follow-Up to Phase 1b Learning Study
(FX-322-111), Some Subjects with Sensorineural Hearing Loss Show
Increased Speech Perception Up to Twelve Months After Dosing
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 human
function, today announced that four additional sensorineural
hearing loss (SNHL) subjects from its FX-322-111 open-label study
achieved statistically significant hearing improvements when
evaluated 8 to 12 months following initial dosing.
Including the five initial responders, there are now a total of
nine subjects that participated in the FX-322-111 study (n=32) that
have been shown to have statistically significant improvements in
word recognition scores, a key measure of speech perception, at
time points between 90 days and one year.
These new results suggest that the hearing of individuals
administered with a single dose of FX-322 may improve over extended
periods. The longer-term measures of their treated ear demonstrated
word recognition score improvements when compared to pre-treatment
baseline levels and no significant changes were detected in their
untreated ears. Of the five subjects that had a statistically
significant response at day-90, the four that returned for
evaluation had scores that remained above their baseline word
recognition measures, though were below the threshold for
statistical significance.
“These insights will guide future studies as we consider
evaluating individuals over longer periods and add further
flexibility to our trial designs, both to maximize the opportunity
to observe these improvements, and better understand when increases
in intelligibility may start to wane,” said David L. Lucchino,
Frequency’s President and Chief Executive Officer. “We also plan to
assess individuals treated in our other studies to evaluate if
those subjects may have experienced these longer-term
benefits.”
FX-322 is Frequency’s lead product candidate for the treatment
of acquired SNHL, which is the primary cause of more than 90
percent of all cases of hearing loss. FX-322 is designed to
regenerate auditory sensory hair cells located in the cochlea
within the inner ear and to potentially restore hearing in
individuals with SNHL.
“These FX-322 data provide important learnings in the
development of a potential hearing loss therapeutic, while showing
meaningful improvements in speech perception,” said Sumit Dhar,
Ph.D., Hugh Knowles Professor of Hearing Science and the Associate
Provost for Faculty at Northwestern University. “The longer
response times from certain study subjects is consistent with what
we have seen with device interventions and would be expected given
the heterogeneity of the auditory system and differences in
etiologies, severities and duration of SNHL.”
The FX-322-111 study is an open-label, multi-center, single-dose
trial designed to evaluate the impact of FX-322 injection
conditions on tolerability, as well as key measures of hearing
benefit. In the study, subjects with mild to severe SNHL (n=33)
were injected in one ear with FX-322, with the untreated ear
serving as the control. Hearing function was tested in 32 subjects
(one subject did not finish the study) over the course of 90 days
following dosing. Twenty-five subjects were subsequently evaluated
at 8-12 months following FX-322 dosing, with four subjects that had
shown improvement trends in word recognition scores at day-90
reaching statistically significant scores when tested at the later
time points.
Subjects in the study had an array of hearing loss etiologies,
including sudden SNHL, noise-induced SNHL and idiopathic SNHL.
Additionally, the subjects ranged in severity from mild to severe.
The single dose had a favorable safety profile and both injection
conditions were well tolerated. Based on the overall learnings from
the multiple FX-322 learning studies, the Company plans to initiate
a new FX-322 Phase 2 trial in the fourth quarter of this year to
evaluate the impact of single-dose FX-322 administration in a
refined population of individuals with SNHL.
An overview of the FX-322-111 study will be shared in a
late-breaking scientific presentation titled, A Second Independent
Phase 1b Demonstrates Hearing Improvement with FX-322, at the
American Academy of Otolaryngology – Head and Neck Surgery Annual
Meeting and OTO experience, on October 4, 2021.
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 (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 initiation, timing and design of the new Phase 2
trial of FX-322, the interpretation and implications of the results
of the FX-322-111 study as well as the results from the follow-up
to the FX-322-111 study, the plan to assess individuals in other
trials for longer-term benefits, the design and timing of future
studies of and clinical development path of FX-322, the treatment
potential of FX-322, and our program to develop a product candidate
for the treatment of multiple sclerosis; 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, the timing of and the
content to be disclosed during the American Academy of
Otolaryngology – Head and Neck Surgery Annual Meeting and OTO
experience, the timing and progress of the Company’s MS program,
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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210922005242/en/
Investor Contact: Carlo Tanzi, Ph.D. Kendall Investor Relations
Email: ctanzi@kendallir.com Tel: 617-914-0008
Media Contact: Suzanne Day Frequency Therapeutics Email:
sday@frequencytx.com Tel: 781-496-2211
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