Frequency Therapeutics Announces First Subject Dosed in FX-322 Phase 2b Acquired Sensorineural Hearing Loss (SNHL) Study and FDA Agreement on Speech Perception as Primary Endpoint

Rhea-AI Summary

Frequency Therapeutics has initiated its FX-322-208 Phase 2b clinical study, focusing on acquired sensorineural hearing loss (SNHL). The randomized, placebo-controlled study will assess speech perception improvements in 124 subjects. The FDA validated speech perception as a primary endpoint in a recent meeting. Previous studies showed significant efficacy, with FX-322 demonstrating safety across 175 patients. An R&D event is scheduled for November 9 to discuss clinical findings and pipeline expansion.

Positive

• Initiation of FX-322-208 Phase 2b study, targeting 124 subjects.
• FDA acceptance of speech perception as primary efficacy endpoint.
• Previous studies indicate significant improvements in speech perception in SNHL patients.
• No serious drug-related adverse events reported across prior trials.

Negative

• Company is not currently profitable and will require additional funding for future development.

FX-322-208 is a Randomized, Placebo-Controlled Study to Evaluate Hearing Improvement in Subjects with Acquired SNHL

Company to Host R&D Event on November 9th to Provide Detailed Review of Completed FX-322 Clinical Studies Supporting FX-322-208 Inclusion Criteria and Study Design

LEXINGTON, Mass.--(BUSINESS WIRE)-- 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 first subject has been dosed in a new FX-322 Phase 2b study (FX-322-208) being conducted in a refined population of individuals with SNHL.

FX-322-208 is a randomized, placebo-controlled, multi-center study designed to evaluate the impact of a single administration of FX-322 on speech perception in approximately 124 subjects with SNHL. The study’s primary endpoint is speech perception, a measure of sound clarity and understanding speech. The Phase 2b study’s inclusion criteria are designed to enroll subjects with the same hearing loss severities and etiologies as those subjects in which statistically significant improvements in speech perception were observed in prior FX-322 clinical studies. FX-322-208 will include subjects with hearing loss associated with either noise-induced or sudden SNHL.

The U.S. Food and Drug Administration (FDA), in a recent Type-C meeting with the Company, agreed that speech perception is an acceptable primary efficacy endpoint. A variety of other listening tests, including multiple measures of speech perception and pure tone thresholds, will also be assessed.

“The FX-322-208 Phase 2b study incorporates learnings from all of our prior studies, enabling us to identify targeted patient populations and prior responder groups for evaluation. We are testing FX-322 in subjects with hearing loss severities and etiologies where we have seen improvements in past trials. We have also applied key additional design elements to the study to mitigate potential bias and help ensure the consistency of baseline hearing assessments,” said David L. Lucchino, Frequency’s Chief Executive Officer. “Moreover, we are very pleased to have obtained alignment with the FDA on speech perception as the primary endpoint for our upcoming studies, given the important need for treatments that can provide greater hearing clarity. In a recently held externally-led Patient Focused Drug Development program with FDA, sponsored by the Hearing Loss Association of America, patients made clear that medicines that could restore hearing and that can enable greater speech perception were critical to advancing the current standard of care. We believe we now have a clear path forward to deliver on this common goal.”

Mr. Lucchino continued: “In November, we look forward to presenting the detailed clinical findings that support the design of FX-322-208, as well as discussing our broader R&D efforts as we expand our pipeline in hearing loss as well as other disease areas where we have seen real promise from our technology.”

In two previous clinical studies, the Company observed statistically significant improvements in speech perception scores in individuals with acquired sensorineural hearing loss. These studies are FX-322-201, a randomized placebo-controlled study of subjects with mild to moderately severe SNHL, and FX-322-111, an open-label study evaluating different FX-322 administration conditions, where nine of 32 subjects that completed the study showed speech perception improvements between 90 days and one year following administration. To date, more than 175 individuals have been dosed with FX-322 across previous studies and no drug-related serious adverse events have been reported.

The Company will maintain flexibility in the overall FX-322-208 design in order to be able to include additional etiologies and severities based on pending results from its ongoing FX-322 study in severe subjects (FX-322-113).

FX-322-208 is expected to be conducted at approximately 25 U.S.-based study sites consisting of both private ENT clinics and academic medical centers. Additional study details are available at clinicaltrials.gov (NCT05086276).

Frequency plans to host an R&D event on November 9, 2021, where the Company will review detailed FX-322 clinical results and discuss the data supporting the design and inclusion criteria for FX-322-208.

Patients with hearing loss who may be interested in participating in FX-322-208 may visit this link, which is also available on the study page at clinicaltrials.gov under “Additional Information.”

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 2b trial of FX-322, including the number of patients that will be enrolled, the type of SNHL that these patients will have, the number of study sites, and the measurements used in the study, the interpretation and implications of the results and learnings of other FX-322 clinical studies, including the FX-322-111, FX-322-201 and FX-322-113 studies, the acceptance by the FDA of particular endpoints in the Company’s trials, the treatment potential of FX-322, the timing of and topics to be discussed during the R&D event, our program to develop a product candidate for the treatment of multiple sclerosis, 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/20211021005166/en/

Investor Contact:

Carlo Tanzi, Ph.D.

Kendall Investor Relations

ctanzi@kendallir.com

617-914-0008

Media Contact:

Suzanne Day

Frequency Therapeutics

sday@frequencytx.com

781-496-2211

Source: Frequency Therapeutics, Inc.

FAQ

What is the FX-322-208 Phase 2b study about?

The FX-322-208 study evaluates the impact of FX-322 on speech perception in subjects with acquired sensorineural hearing loss.

When will Frequency Therapeutics discuss the FX-322 clinical findings?

Frequency Therapeutics will host an R&D event on November 9 to review detailed clinical results.

How many subjects are involved in the FX-322-208 study?

Approximately 124 subjects with acquired sensorineural hearing loss will participate in the study.

What has the FDA said about the FX-322-208 study?

The FDA has agreed that speech perception is an acceptable primary efficacy endpoint for the study.

What previous results support the FX-322 study?

Past studies have shown statistically significant improvements in speech perception in patients with similar conditions.