Frequency Therapeutics shares results from study FX-322-113 in severe sensorineural hearing loss showing improvements in speech perception in noise


LEXINGTON, Mass., December 9, 2021– (COMMERCIAL THREAD) – Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapies to activate a person’s innate regenerative potential to restore function, today shared the results of its study FX-322-113, a placebo-controlled trial evaluating the administration of FX-322 in subjects with severe sensorineural hearing loss (SNHL). In the study, FX-322 was associated with an auditory signal, as shown by improvements in four subjects in a sentence-in-noise test.

FX-322-113 is a phase 1b, double-blind, placebo-controlled study designed to assess the local and systemic safety of a single dose of FX-322, and to assess auditory responses in a cohort of people with severe SNHL (pure tone mean deficit between 71 and 90 decibels (dB) in hearing level), a patient population who may have considerable damage to their inner ears and where cochlear implants may be the only potential intervention to improve hearing. Subjects were randomized 4: 1 and received either FX-322 or placebo in one ear. Safety, otologic and audiologic evaluations were performed on days 30 and 90 after administration of FX-322 or placebo.

To better understand the potential impact of FX-322 in this population, the company assessed hearing function using several tests of speech perception in quiet and noisy environments, including the Bamford-Kowal exam. Bench Sentence-in-Noise (BKB-SIN). BKB-SIN is a validated test designed for severe populations of SNHL (including cochlear implant patients), measuring the change in signal-to-noise ratios (SNRs) required for a subject to correctly repeat the words of a sentence.

In study FX-322-113, improvements in the BKB-SIN test were seen in four subjects, all of which exceeded the 95% critical difference of 3.1 dB SNR, with two subjects exhibiting a 6 dB response . Only one patient on placebo experienced a 3.6 dB change. In the study, subjects did not show substantial changes in measures of speech perception in calm, the safety profile of the study was favorable, and no serious treatment-related adverse events were observed. reported.

“Given the level of cochlear injury, identifying single words in any audiological test can be very difficult for these people. The response to the BKB-SIN test and a 6 dB improvement in signal-to-noise ratio in several severe subjects are very encouraging. and consistent with the improvement we see in some patients after cochlear implantation, ”said René Gifford, Ph.D., professor and director of the Cochlear Implant Research Laboratory, Department of Hearing and Hearing Sciences. speaking at Vanderbilt University and a member of Frequency’s Clinical Advisory Board. “It’s the real-world equivalent of being able to halve the distance between two people in a conversation, which can have a huge impact on an individual’s ability to communicate and engage in conversation. company. It is exciting to consider the potential of restorative therapy as a component of the treatment paradigm for people with severe SNHL, either as stand-alone treatment or in combination with hearing technologies such as hearing aids and cochlear implants. , to improve patient outcomes. “

Brian Monson, Ph.D., assistant professor in the Department of Speech and Hearing Sciences at the College of Applied Health Sciences at the University of Illinois added: The cochlea, as well as the mechanism of proposed action, these promising results suggest both an auditory signal and potential functional improvements enabling speech perception in a noisy environment. These study results are important because this result can currently only be achieved using hearing aids that amplify sound, further highlighting the potential for a restorative intervention to improve speech clarity. “

The FX-322 is Frequency’s flagship product candidate for hearing restoration and is designed to regenerate auditory hair cells to restore hearing function. Frequency is currently recruiting a new Phase 2b study (FX-322-208) in subjects with sudden or noise-induced sensorineural hearing loss, with hearing loss severities predominantly in the moderate to moderately severe ranges (35 to 85 dB ).

“This is the third FX-322 study where we have observed an auditory signal, increasing our confidence in our clinical program and the potential for a regenerative treatment for sensorineural hearing loss. The lessons from this study and all of our Early phase studies to date have provided Frequency, and the field at large, with important insights as we broaden our understanding of how our therapeutic candidate can deliver clinically meaningful benefits to the millions of people with SNHL who have not. today no restorative treatment option, ”said David L. Lucchino, Managing Director of Frequency.

About frequency therapy

Frequency Therapeutics leads a new category in regenerative medicine that aims to restore function – first in hearing loss, then in multiple sclerosis (MS) – by developing therapies that activate a person’s innate regenerative potential in the body. body by activating progenitor cells to restore lost function. Frequency’s hearing research focuses on cochlear restoration and hearing repair, and its core active ingredient, FX-322, is a small molecule candidate that is the first to show statistically significant and clinically significant hearing improvements in trials. clinics for SNHL. The frequency also follows the first restorative signals in MS to develop drugs with the same underlying regenerative science applied to hearing loss.

Based in Lexington, Mass., Frequency has an ex-US licensing and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and research organizations for the purpose. nonprofits, including Massachusetts Eye and Ear, Mass General Brigham, Massachusetts Institute of Technology, Scripps Research Institute, and Cambridge Enterprises Limited. For more information visit www.fré 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 historical facts should be considered as forward-looking statements, including, without limitation, statements regarding the interpretation and implication of the results and lessons of FX-322-113, the timing and design of the new phase 2b trial of FX-322, including the type of SNHL that enrolled patients will have, the processing potential of FX-322, the ability of our technology platform to deliver patient benefits, the ability to continue to develop our progenitor cell activation (PCA) platform, and to identify other product candidates, and the potential application of the PCA platform to other diseases, including MS.

These forward-looking statements are based on the current expectations of management. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors which may cause actual results, performances or achievements to differ materially from the future results, performances or achievements expressed or implied by forward-looking statements. , including, but not limited to the following: the impact of COVID-19 on ongoing and planned clinical trials, research and development and manufacturing activities, operations and financial markets of the Company ; the Company has suffered and will continue to suffer significant losses and is not and may never be profitable; the Company’s need for additional funding to complete the development and commercialization of any product candidates; the Company’s dependence on the development of FX-322; the unproven approach of the PCA platform and the inability to identify other potential product candidates; the lengthy, costly and uncertain process of clinical drug development and regulatory approval; the Company’s limited experience in successfully obtaining marketing approval and commercialization of product candidates; the results of previous clinical trials are not indicative of the results of subsequent clinical trials; differences between preliminary or intermediate data and final data; adverse events or unwanted side effects; disruptions from the FDA and other regulatory agencies; the inability to identify other product candidates; new or amended legislation; failure to maintain the Fast Track designation for the FX-322 and such designation does not result in faster development or regulatory review or approval; the ability to seek and receive the revolutionary therapy designation for the FX-322; the Company’s ability to recruit and retain patients in clinical trials; costly and damaging litigation, including litigation relating to product liability or intellectual property or brought by shareholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; the use of third parties, including to conduct clinical trials and manufacture product candidates; compliance with changing laws and regulations, including health care and environmental, health, data privacy and security laws and regulations; failure to obtain, maintain and enforce patent protection and other intellectual property rights covering product candidates; security breaches or failure to protect private personal information; attract and retain key personnel; and the Company’s ability to manage growth.

These and other important factors discussed under “Risk Factors” in the Company’s Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 15, 2021 and its other reports filed with the SEC could result in a substantial difference in actual results. those indicated by the forward-looking statements contained in this press release. These forward-looking statements represent management’s estimates as of the date of this press release. Although the Company may choose to update these forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its point of view to change. These forward-looking statements should not be taken as representing the views of the Company as of a date subsequent to the date of this press release.

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Investor contact:
Carlo Tanzi, Ph.D.
Kendall Investor Relations
[email protected]

Media contact:
Suzanne Day
Frequency therapy
[email protected]é

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