WOBURN, MASSACHUSSETTS — Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage biotechnology company focused on harnessing the body’s innate biology to repair or reverse damage caused by a broad range of degenerative diseases, has announced the completion of enrollment of its Phase 2a study of FX-322 for sensorineural hearing loss (SNHL).
The company anticipates obtaining full results for the study, in which 95 patients were enrolled, in the second quarter of 2021.
“We are pleased to have completed an important next step toward offering a potential breakthrough medicine for millions of people with acquired sensorineural hearing loss and look forward to sharing the full results of the Phase 2a study next year. A critical need for patients with hearing loss is improving the clarity of sound, a basic function that is essential for day-to-day engagement with family and colleagues, and even more so today as many of us communicate remotely. Hearing health is essential for overall health, and our hope is that our new potential restorative therapy also may help address the risks of depression, isolation and dementia associated with long-term hearing loss.”
–Frequency Therapeutics CEO, David L. Lucchino
“We deeply appreciate the commitment and compliance of all of the patients that participated in this study, as well as the efforts of our clinical partners, particularly given the challenges posed by the pandemic,” said Frequency CEO, David Lucchino.
FX-322: Treating Sensorineural Hearing Loss
FX-322 is Frequency’s lead product candidate for the treatment of acquired SNHL, which impacts more than 40 million people in the U.S. and hundreds of millions of people globally. SNHL is the primary cause of more than 90 percent of all cases of hearing loss. FX-322 is designed to regenerate auditory sensory hair cells located in the cochlea within the inner ear and to potentially restore hearing in patients with SNHL.
Acquired SNHL results from damage to the hair cells in the inner ear that normally convert sound waves from the inner ear into signals that are sent to the brain. These auditory sensory hair cells may be lost due to chronic noise exposure, aging, certain viral infections or exposure to drugs that are toxic to the ear.
The Phase 2a study is a randomized, double blind, placebo-controlled, single- and repeat-dose study which enrolled 95 patients, aged 18 to 65, with stable SNHL.
Patients in the study were randomized into four dose cohorts and hearing function is being regularly tested over the course of seven months following the first dosing. FX-322 Phase 2a study subjects are randomized to receive either FX-322 or placebo in one ear, with the untreated ear acting as an additional measure of control.
The objectives of the Phase 2a study are to further establish the hearing signal observed in the completed Phase 1/2 study, evaluate the impact of multiple doses and provide deeper insights on endpoints and the appropriate patient population for future studies. The study is using validated measures of hearing function including word recognition, words-in-noise and pure tone audiometry. Tinnitus and quality-of-life measures will also be evaluated using the Tinnitus Functional Index and the Hearing Handicap Inventory for Adults, respectively.
About Frequency Therapeutics
Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The company’s progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The company’s lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. In an FX-322 Phase 1/2 study, statistically significant and clinically meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss were observed. FX-322 is being evaluated in an ongoing Phase 2a clinical study in patients with sensorineural hearing loss. The company also is evaluating additional diseases where its PCA approach could create functional tissue, including a discovery program in multiple sclerosis. Headquartered in Woburn, Mass., Frequency has a license and collaboration agreement with Astellas Pharma Inc. for FX-322, for which it retains U.S. rights, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including The Scripps Research Institute, Cambridge Enterprises Limited, Massachusetts Eye and Ear, Mass General Brigham and the Massachusetts Institute of Technology