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 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.

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