Frequency Therapeutics Virtual R&D Event to Detail FX-322 Clinical Advances, a New Program for Hearing Restoration and In Vivo Data from its MS Remyelination Program
27 October 2021 - 10:30PM
Business Wire
At Nov. 9 Event, Management and Key Opinion
Leaders to Review Detailed FX-322 Clinical Study Results in
Patients with Sensorineural Hearing Loss (SNHL) and Design of New
FX-322-208 Phase 2b Study
Company to Introduce a Second Hearing
Restoration Program with a Differentiated Biological Profile and
Greater Coverage into the Cochlea, Providing Potential to Expand
Addressable SNHL Patient Populations
Key Research Findings for a Novel Remyelinating
Agent Being Advanced for Multiple Sclerosis (MS) also to be
Presented
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 Company will be hosting a
virtual R&D event on November 9, 2021.
At the event, Frequency’s clinical leaders will provide a
detailed review of data from nearly 170 subjects dosed with FX-322.
A rigorous statistical analysis of these clinical data uncovered
the patient populations most likely to benefit from FX-322 and
these patients are now being recruited in the Company’s recently
initiated FX-322 Phase 2b study (FX-322-208). Key opinion leaders
in auditory science and clinical study design will provide insights
on FX-322 clinical results and the strategy supporting the new
FX-322-208 trial.
The FX-322-208 study is designed to demonstrate improved speech
perception in an enriched population of individuals with SNHL where
statistically significant and clinically meaningful hearing
improvements in speech perception were observed in prior trials.
The U.S. Food and Drug Administration (FDA) recently agreed with
speech perception as the primary endpoint for FX-322 development,
including for the FX-322-208 study and all future FX-322
studies.
In addition to discussing clinical development advances, the
company will unveil two new advanced research programs:
- A new candidate to treat sensorineural hearing loss that
delivers a regenerative therapeutic that may provide greater
coverage and increased potency at the site of action within the
inner ear, that may enable the treatment of different SNHL patient
populations at varying dose levels and;
- A novel approach for remyelination in multiple sclerosis,
including in vivo findings showing potent biological activity and a
comparison of this program to other leading approaches.
Event Details and Agenda:
The webcast event is scheduled for November 9 from 8 a.m. to 10
a.m. ET, and will include a live Q&A session. Following are the
list of management and key opinion leaders that are expected to
present and their areas of focus:
- David L. Lucchino, Chief Executive Officer: Strategic
Company overview.
- Robert S. Langer, ScD, a Frequency Therapeutics scientific
co-founder and MIT Institute Professor: Pioneering a new
category in regenerative medicine.
- Carl LeBel, PhD, Chief Development Officer: FX-322
hearing restoration program and the clinical development path.
- Sumit Dhar, PhD, Hugh Knowles Professor of Hearing Science
and Associate Provost for Faculty at Northwestern University:
Cochlear pathology and the impact of high frequencies on speech
perception.
- Kevin Franck, PhD, SVP, Strategic Marketing and New Product
Planning: FX-322 clinical data and review of responders.
- Steven D. Targum, MD, Scientific Director, Signant
Health: Best-practice approaches for addressing placebo
response in clinical trials.
- Christopher Loose, PhD, Chief Scientific Officer:
Continued progenitor cell activation (PCA) research, drug delivery
advances and overview of a new regenerative hearing program.
- Sanjay Magavi, PhD, VP, Myelination Research: In Vivo
data for a novel pre-clinical program for remyelination in multiple
sclerosis.
To register for the virtual event and watch a live webcast of
the presentation, please visit the Investor’s & Media section
of the Frequency Therapeutics website at
https://investors.frequencytx.com/2021_Virtual_R-D_Event. An
archived replay will be available for at least 30 days following
the presentation.
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 2 trial of FX-322, including,
the type of SNHL that the enrolled patients will have, the
interpretation and implications of the results and learnings of
other FX-322 clinical studies, the acceptance by the FDA of
particular endpoints in the Company’s trials, the treatment
potential of FX-322 as well as the novel approach for remyelination
in multiple sclerosis and our new candidate to treat SNHL, the
speakers, timing of and topics to be discussed during the R&D
event,, 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/20211027005536/en/
Investors: Carlo Tanzi, Ph.D. Kendall Investor Relations
ctanzi@kendallir.com 617-914-0008 Media: Suzanne Day Frequency
Therapeutics sday@frequencytx.com 781-496-2211
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