FX-322-208 is a Randomized, Placebo-Controlled
Study to Evaluate Hearing Improvement in Subjects with Acquired
SNHL
Company to Host R&D Event on November 9th
to Provide Detailed Review of Completed FX-322 Clinical Studies
Supporting FX-322-208 Inclusion Criteria and Study Design
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 announced that the first subject has been dosed in
a new FX-322 Phase 2b study (FX-322-208) being conducted in a
refined population of individuals with SNHL.
FX-322-208 is a randomized, placebo-controlled, multi-center
study designed to evaluate the impact of a single administration of
FX-322 on speech perception in approximately 124 subjects with
SNHL. The study’s primary endpoint is speech perception, a measure
of sound clarity and understanding speech. The Phase 2b study’s
inclusion criteria are designed to enroll subjects with the same
hearing loss severities and etiologies as those subjects in which
statistically significant improvements in speech perception were
observed in prior FX-322 clinical studies. FX-322-208 will include
subjects with hearing loss associated with either noise-induced or
sudden SNHL.
The U.S. Food and Drug Administration (FDA), in a recent Type-C
meeting with the Company, agreed that speech perception is an
acceptable primary efficacy endpoint. A variety of other listening
tests, including multiple measures of speech perception and pure
tone thresholds, will also be assessed.
“The FX-322-208 Phase 2b study incorporates learnings from all
of our prior studies, enabling us to identify targeted patient
populations and prior responder groups for evaluation. We are
testing FX-322 in subjects with hearing loss severities and
etiologies where we have seen improvements in past trials. We have
also applied key additional design elements to the study to
mitigate potential bias and help ensure the consistency of baseline
hearing assessments,” said David L. Lucchino, Frequency’s Chief
Executive Officer. “Moreover, we are very pleased to have obtained
alignment with the FDA on speech perception as the primary endpoint
for our upcoming studies, given the important need for treatments
that can provide greater hearing clarity. In a recently held
externally-led Patient Focused Drug Development program with FDA,
sponsored by the Hearing Loss Association of America, patients made
clear that medicines that could restore hearing and that can enable
greater speech perception were critical to advancing the current
standard of care. We believe we now have a clear path forward to
deliver on this common goal.”
Mr. Lucchino continued: “In November, we look forward to
presenting the detailed clinical findings that support the design
of FX-322-208, as well as discussing our broader R&D efforts as
we expand our pipeline in hearing loss as well as other disease
areas where we have seen real promise from our technology.”
In two previous clinical studies, the Company observed
statistically significant improvements in speech perception scores
in individuals with acquired sensorineural hearing loss. These
studies are FX-322-201, a randomized placebo-controlled study of
subjects with mild to moderately severe SNHL, and FX-322-111, an
open-label study evaluating different FX-322 administration
conditions, where nine of 32 subjects that completed the study
showed speech perception improvements between 90 days and one year
following administration. To date, more than 175 individuals have
been dosed with FX-322 across previous studies and no drug-related
serious adverse events have been reported.
The Company will maintain flexibility in the overall FX-322-208
design in order to be able to include additional etiologies and
severities based on pending results from its ongoing FX-322 study
in severe subjects (FX-322-113).
FX-322-208 is expected to be conducted at approximately 25
U.S.-based study sites consisting of both private ENT clinics and
academic medical centers. Additional study details are available at
clinicaltrials.gov (NCT05086276).
Frequency plans to host an R&D event on November 9, 2021,
where the Company will review detailed FX-322 clinical results and
discuss the data supporting the design and inclusion criteria for
FX-322-208.
Patients with hearing loss who may be interested in
participating in FX-322-208 may visit this link, which is also
available on the study page at clinicaltrials.gov under “Additional
Information.”
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 design of the new Phase 2b trial of FX-322, including
the number of patients that will be enrolled, the type of SNHL that
these patients will have, the number of study sites, and the
measurements used in the study, the interpretation and implications
of the results and learnings of other FX-322 clinical studies,
including the FX-322-111, FX-322-201 and FX-322-113 studies, the
acceptance by the FDA of particular endpoints in the Company’s
trials, the treatment potential of FX-322, the timing of and topics
to be discussed during the R&D event, 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, 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/20211021005166/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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