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.
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.
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.