Regenerative Treatment Designed to Increase
Drug Exposure Through the Cochlea; Study Results Expected in H2
2023
Frequency’s Lead Hearing Program, FX-322, on
Track for Phase 2b Topline Results in Q1 2023
Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage
regenerative medicine company focused on developing therapeutics to
activate a person’s innate potential to restore function, today
announced that it has dosed a first patient in the Phase 1b study
of FX-345, the Company’s second hearing restoration candidate for
sensorineural hearing loss (SNHL).
FX-345 is a combination of two small molecules and, similar to
Frequency’s lead hearing candidate FX-322, is designed to restore
inner ear cells needed for hearing. However, FX-345 includes a more
potent GSK3 inhibitor, a new chemical entity that may enable
targeted drug exposure further into the cochlea. Future clinical
studies will determine whether greater cochlear drug exposure can
address additional populations of individuals with SNHL.
“Advancing FX-345 to the clinic is an exciting milestone as we
further our pioneering work to develop regenerative therapeutics
for hearing loss. By expanding our hearing pipeline, we hope to
better understand the breadth of SNHL types and severities we may
be able to treat, and we look forward to FX-345 Phase 1b study data
in the second half of next year,” said Frequency’s Chief Executive
Officer David L. Lucchino. “I am pleased with our team’s work to
advance small molecule drug delivery, enabling us to explore the
impact of reaching further into the cochlea to build upon our
understanding of how our approach may restore human hearing.”
The Phase 1b trial, FX-345-101, is a prospective, randomized,
single-blind, placebo-controlled, multicenter study to evaluate the
safety of FX-345, administered as a single intratympanic injection,
in approximately 36 adults aged 18-67, with adult-onset acquired
SNHL. The study is divided into two cohorts, with an initial safety
cohort of nine subjects designed to provide a rapid assessment of
safety and drug exposure. Pending favorable safety results, a
second cohort of 27 subjects will be dosed to continue the safety
assessment and evaluate whether FX-345 favorably improves measures
of auditory function. Within each cohort, subjects will be
randomized 2:1 to receive a single dose of FX-345 or placebo.
In pre-clinical studies, pharmacokinetic measures and computer
modeling data suggest that FX-345 administration in this trial may
result in therapeutically active drug levels in a broad portion of
the human cochlea. The Company anticipates delivering clinical
results in the second half of 2023.
Frequency is also evaluating FX-322, a therapeutic candidate for
SNHL, in an ongoing Phase 2b study (FX-322-208). The prospective,
randomized, double-blinded, placebo-controlled, multi-center study
is designed to evaluate the efficacy of FX-322 on speech perception
in subjects aged 18-65 with hearing loss associated with either
noise-induced or permanent idiopathic sudden SNHL. The study is
fully enrolled with 142 participants and clinical results are
expected in the second half of Q1 2023.
About Sensorineural Hearing Loss
Sensorineural hearing loss is the most common form of hearing
loss, typically resulting from damage to sensory hair cells in the
cochlea. These cells convert sound waves to signals sent to the
brain which are interpreted as speech and sound. Sensory hair cells
are lost due to chronic noise exposure, aging, certain viral
infections or exposure to drugs that are toxic to the ear. This
type of hearing loss impacts around 40 million individuals in the
U.S. alone.
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 – 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 combination
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
similar underlying regenerative science being brought to hearing
loss.
Headquartered in Lexington, Frequency has an ex-U.S. license and
collaboration agreement with Astellas Pharma Inc. for certain
hearing loss products, which includes FX-322 and FX-345, 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, and the Scripps Research Institute.
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 timing of the Phase 1b study of FX-345 and Phase 2b
study of FX-322, including the timing of results, the treatment
potential of FX-322, FX-345, and the MS program, estimates of the
size of the hearing loss population, and the potential application
of the progenitor cell activation (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 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221215005106/en/
Investor: Carlo Tanzi, Ph.D. Kendall Investor Relations
ctanzi@kendallir.com 617-914-0008 Media: Frequency Therapeutics
Email: media@frequencytx.com
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