Frequency Therapeutics Announces Topline Results for its Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss
February 13 2023 - 8:05AM
Business Wire
FX-322-208 Study Fails to Meet Primary
Endpoint, Showing No Significant Separation in Speech Perception
Between FX-322 and Placebo
Company Will Now Focus on Advancing its Program
in Remyelination for Multiple Sclerosis (MS)
Announces Corporate Restructuring and Will Also
Explore Strategic Financing Alternatives; Net of Debt, has Cash and
Marketable Securities of $68.9mm as of December 31, 2022
Frequency Therapeutics, Inc. (Nasdaq: FREQ), a regenerative
medicine company focused on developing therapeutics to activate a
person’s innate potential to restore function, today announced
clinical results from the placebo-controlled Phase 2b study of
FX-322 in individuals with acquired Sensorineural Hearing Loss
(SNHL).
The study, which enrolled 142 people with either sudden or
noise-induced sensorineural hearing loss, failed to achieve its
primary efficacy endpoint of an improvement in speech perception.
Data showed no statistically meaningful difference at day 90
between those administered FX-322 versus those receiving placebo in
the proportion of individuals that demonstrated an improvement in
speech perception. There were also no measurable improvements
observed in any of the study’s secondary endpoints. Prior FX-322
studies had been designed to best understand patient etiologies and
severities where a hearing signal could be observed. FX-322-208 was
statistically powered with a balanced placebo and active group. The
safety profile associated with FX-322 was favorable and no study
participants experienced a serious adverse event that was
associated with treatment.
The Company will now discontinue the FX-322 development program.
In addition, while dosing of FX-345, a second program to treat
SNHL, has been completed in the initial safety cohort of an ongoing
Phase 1b trial, that development program will also be discontinued.
The Company will now focus its resources to advance its
remyelination in MS program into the clinic.
“This was a rigorous and well-designed study that provided us a
clear outcome, though not the outcome we wanted. Given these
disappointing results, we will cease further development of the
Company's drug candidates for hearing loss. We are thankful to the
patients, clinicians and their staffs, and the experts from our
clinical advisory board who helped us to design and run a
conclusive study in SNHL. We hope the learnings from our studies
will benefit the field and ultimately support the successful
development of future treatments for hearing loss,” said Chris
Loose, Ph.D., Frequency’s chief scientific officer.
Frequency’s efforts now will focus on continuing to develop
novel therapeutics to induce remyelination for individuals living
with MS. The Company previously reported that it had identified a
novel target relevant to myelination. Modulation of this target
drives robust oligodendrocyte differentiation and expression of
myelin proteins in vitro. The Company has identified multiple novel
chemical entities that induce robust remyelination following
demyelination in an adult in vivo animal model. The MS program is
independent of the hearing program, with a distinct molecular
target, mechanism, progenitor cell population, and small molecule
drug candidates. Further, a well-defined clinical path with
objective biomarkers such as visual evoked potential (VEP) and
magnetic resonance imaging (MRI) exist for studying the performance
of remyelination therapies in MS patients. Frequency’s agents
substantially outperform other clinically studied remyelination
agents in head-to-head in vivo studies. Frequency plans to begin
its clinical program for remyelination in 1H 2024.
The Company will immediately reduce headcount as part of an
overall restructuring, downsizing personnel by approximately 55
percent. The Company believes that the restructuring will generate
sufficient cost savings to extend its runway into 2025 and enable
it to complete a first clinical trial of its MS program in 2H 2024.
As of December 31, 2022, Frequency had cash, cash equivalents and
marketable securities of $83.1 million (excluding restricted
cash).
Business Updates
The Company shared today that Chief Executive Officer David
Lucchino is on temporary medical leave after having been
hospitalized with bacterial meningitis. Mr. Lucchino is expected to
make a full recovery and return to his role in the coming weeks.
Its Board of Directors has appointed Chris Loose, CSO, as Interim
CEO until Mr. Lucchino returns.
About Frequency Therapeutics
Headquartered in Lexington, Mass., Frequency Therapeutics is
pioneering a new category in regenerative medicine that aims to
restore human function by developing therapeutics that activate a
person’s innate regenerative potential within the body through the
activation of progenitor cells. The Company’s lead preclinical
program is designed to activate oligodendrocyte precursor cells
with the goal of driving remyelination and potential functional
recovery for individuals living with multiple sclerosis. 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 treatment potential and timing of Frequency
Therapeutics’ (the “Company”) remyelination program in multiple
sclerosis (“MS Program”), including the timing of clinical
development, the potential application of the regenerative medicine
platform to other diseases, the ability of our regenerative
medicine platform to provide patient benefit, Mr. Lucchino’s return
to his role as chief executive officer, and the sufficiency of the
Company’s capital resources.
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 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 pre-clinical
studies not being indicative of the results from clinical trials;
adverse events or undesirable side effects; disruptions at the FDA
and other regulatory agencies; failure to identify additional
product candidates; new or changed legislation; costly and damaging
litigation, including related to product liability or intellectual
property or brought by stockholders; 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/20230213005212/en/
Investors: Carlo Tanzi, Ph.D. Kendall Investor Relations
ctanzi@kendallir.com 617-914-0008 Media: Frequency Therapeutics
Email: media@frequencytx.com
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