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 shared the results from its FX-322-113 study, a
placebo-controlled trial evaluating the administration of FX-322 in
subjects with severe sensorineural hearing loss (SNHL). In the
study, FX-322 was associated with a hearing signal as shown by
improvements by four subjects in a sentence-in-noise test.
FX-322-113 is a double-blind, placebo-controlled Phase 1b study
designed to assess the local and systemic safety of a single dose
of FX-322, and to evaluate hearing responses in a cohort of
individuals with severe SNHL (pure tone average deficit between
71-90 decibel (dB) hearing level), a patient population that may
have considerable damage to their inner ears and where cochlear
implants may be the only potential intervention to improve hearing.
Subjects were randomized 4:1 and received either FX-322 or placebo
in one ear. Safety, otologic and audiologic assessments were
conducted at days 30 and 90 following administration of FX-322 or
placebo.
To gain a more comprehensive understanding of the potential
impact of FX-322 in this population, the Company evaluated hearing
function using multiple tests of speech perception in both quiet
and noisy backgrounds, including the Bamford-Kowal-Bench
Sentence-in-Noise exam (BKB-SIN). BKB-SIN is a validated test
designed for severe SNHL populations (including cochlear implant
patients), measuring the change in signal-to-noise ratios (SNR)
required for a subject to correctly repeat words in a sentence.
In the FX-322-113 study, BKB-SIN test improvements were observed
in four subjects, all of whom exceeded the 95 percent critical
difference of 3.1 dB SNR, with two subjects showing a 6 dB
response. A single placebo patient had a 3.6 dB change. In the
study, subjects did not show substantial changes in speech
perception measures in quiet, the safety profile in the study was
favorable and there were no treatment-related serious adverse
events reported.
“Given the level of cochlear damage, identifying single words in
any audiologic test can be very challenging for these individuals.
Response to the BKB-SIN test and a 6 dB improvement in the
signal-to-noise ratio in multiple severe subjects is highly
encouraging and consistent with the improvement we see in some
patients following cochlear implantation,” said René Gifford,
Ph.D., Professor and Director, Cochlear Implant Research Laboratory
Department of Hearing and Speech Science at Vanderbilt University
and a member of Frequency’s clinical advisory board. “This is the
real-world equivalent to being able to halve the distance between
two people in a conversation, which can be very impactful on an
individual’s ability to communicate and engage in society. It is
exciting to consider the potential of a restorative therapeutic as
a component of the treatment paradigm for individuals with severe
SNHL, either as a stand-alone treatment or in combination with
hearing technology such as hearing aids and cochlear implants, to
improve patient outcomes.”
Brian Monson, Ph.D., an assistant professor in the Department of
Speech and Hearing Science in the College of Applied Health Science
at the University of Illinois added: “Based on data pointing to
FX-322 being localized in the higher frequency portion of the
cochlea, as well as the proposed mechanism of action, these
promising results are suggestive both of a hearing signal and
potential functional improvements enabling speech perception in a
noisy environment. These study findings are important as this
outcome cannot currently be achieved using hearing devices that
amplify sound, further highlighting the potential for a restorative
intervention to enhance speech clarity.”
FX-322 is Frequency’s lead hearing restoration product candidate
and is designed to regenerate auditory hair cells to restore
hearing function. Frequency currently is enrolling a new Phase 2b
(FX-322-208) study of subjects with noise-induced or sudden
sensorineural hearing loss, with hearing loss severities primarily
in the moderate to moderately severe ranges (35 – 85 dB).
“This is the third FX-322 study where we have observed a hearing
signal, furthering our confidence in our clinical program and the
potential of a regenerative treatment for sensorineural hearing
loss. The learnings from this study, and all of our early-phase
studies to date, have provided Frequency and the field overall with
important insights as we extend our understanding of how our
therapeutic candidate may provide clinically meaningful benefit to
the millions of individuals with SNHL that today have no
restorative treatment options,” said David L. Lucchino, Frequency’s
Chief Executive Officer.
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 to restore lost
function. 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 SNHL. 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 interpretation and implication of the results and
learnings of FX-322-113, the timing and design of the new Phase 2b
trial of FX-322, including the type of SNHL that the enrolled
patients will have, the treatment potential of FX-322, 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,
including MS.
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 15, 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/20211209005182/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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