Frequency Therapeutics to Host Virtual Investor Event, Highlighting Hearing Restoration Candidate FX-322 in Advance of Q1 Clinical Results
November 17 2022 - 7:30AM
Business Wire
December 13 Program to Review FX-322 Phase 2b
Study and Endpoints, Physician Demand for Interventions to Treat
Sensorineural Hearing Loss and Market Opportunity
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 will host a virtual investor event on December
13, 2022, with a focus on FX-322, the Company’s lead hearing
restoration candidate for acquired sensorineural hearing loss
(SNHL). A Phase 2b study of FX-322 (FX-322-208) is fully enrolled
with clinical results anticipated in the first quarter of 2023.
At the event, Company management will review the FX-322-208
study design, the patient populations targeted for enrollment,
pre-specified speech perception endpoints, and the potential FX-322
commercial market opportunity. Key opinion leaders (KOLs) in
auditory science and otolaryngology will provide insights on the
potential impact of a pharmaceutical intervention for patients with
SNHL. They will also discuss how a medicine for cochlear
regeneration may fit with currently available hearing devices and
the clinical significance of speech perception on overall
hearing.
Event Details and
Registration:
The webcast is scheduled for Tuesday, December 13, 2022, from
8:00 to 9:00 a.m. EST, and will include a live Q&A after the
presentations. Following is the list of management and KOLs
expected to participate:
- David L. Lucchino, Chief Executive Officer: Strategic
Company overview and pipeline updates.
- Kevin Franck, Ph.D., SVP, Strategic Marketing and New
Product Planning: Cochlear restoration market development and
the demand for new therapeutics.
- Carl LeBel, Ph.D., Chief Development Officer: FX-322
hearing restoration program and the clinical development path.
- Christina Runge, Ph.D., Professor of Otolaryngology
and Communication Sciences, Medical College of Wisconsin:
Challenges faced by individuals with speech perception and word
discrimination deficits.
- Anthony Mikulec, MD, Professor of Otology & Neurotology
at St. Louis University and SSM Health: Current treatment
paradigms and the clinical opportunity to introduce pharmaceutical
interventions for SNHL.
To register for the event, please click here. The live and
archived webcast will be available on the Investors page of the
Company’s website at https://investors.frequencytx.com.
FX-322 Phase 2b Study (FX-322-208)
FX-322-208 is a prospective, randomized, double-blinded,
placebo-controlled, multi-center Phase 2b study designed to
evaluate the efficacy of a single administration of FX-322 in a
pre-specified measure of speech perception in subjects aged 18-65
with hearing loss associated with either noise-induced or permanent
idiopathic sudden SNHL. In prior studies, the Company observed the
greatest concentration of speech perception improvements in
individuals with permanent sudden or noise-induced sensorineural
hearing loss in the moderate to lower severe hearing loss range. In
October, the Company announced it had completed Phase 2b study
enrollment of 142 individuals aligned with these etiologies and
severities. More than 200 individuals have been dosed with a single
injection of FX-322 in prior or ongoing studies and the drug
candidate has exhibited a favorable safety profile with no
drug-related serious adverse events.
About Acquired SNHL
Acquired sensorineural hearing loss is the most common form of
hearing loss, typically resulting from damage to sensory hair cells
in the cochlea. Sensory hair cells are lost due to chronic noise
exposure, aging, certain viral infections, ototoxic drugs, or can
even result from sudden, unknown (idiopathic) causes. This type of
hearing loss impacts around 40 million individuals in the U.S. and
more than one billion people globally.
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, 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, 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 and design of the Phase 2b study (FX-322-208),
including the timing of results, patient population enrolled, and
the ability of design features to reduce bias, the interpretation
and implications of the results and learnings of other FX-322
clinical studies, the treatment potential and commercial market
opportunity of FX-322, estimates of the size of the hearing loss
population, the speakers, timing of and topics to be discussed
during the investor event, 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/20221117005270/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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