Tarrytown, New York, March 11, 2022 (GLOBE NEWSWIRE) -- ENT and Allergy Associates, LLP (ENTA), the largest ear, nose, throat, allergy, and audiology practice in the nation, which continuously strives to encourage and promote the very best medical advancements in the fields of otolaryngology, immunology, and audiology announced today that it is currently participating in a nationwide clinical trial of a novel regenerative medicine designed to restore hearing in patients with acquired sensorineural hearing loss (SNHL). Led by ENTA’s fellowship-trained otologist/neurotologist Sujana Chandrasekhar, MD, FACS, its New York City office currently is enrolling subjects in a study of the drug candidate FX-322, being developed by Frequency Therapeutics.
Frequency Therapeutics, Inc. is a clinical-stage regenerative medicine company focused on developing therapeutics to activate a person’s innate regenerative potential to restore function. FX-322 is designed to regenerate cells in the ear lost to acquired SNHL and, to date, has shown hearing improvements in key measures of hearing function in three separate studies in which a single dose of FX-322 was administered.
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 hearing loss associated with either noise-induced or sudden SNHL, the types of hearing loss where improvements in speech perception were observed in prior FX-322 clinical studies. The study’s primary goal is to show improvements in speech perception, a measure of sound clarity and understanding speech.
Sensorineural Hearing Loss (SNHL) is the most prevalent form of hearing loss and is typically acquired through excessive noise exposure or loud sounds over extended periods of time. It can also be caused by infections, immune system problems, trauma, toxic exposures to certain medications, or even just getting older.
Dr. Chandrasekhar says, “We know that regenerative medicine holds limitless potential uses—and restoring speech perception in patients with sensorineural hearing loss is one of the most important uses I can think of. I am humbled and honored to be a part of this game-changing, hearing restoration project that has the potential to changes people’s lives in an extraordinary way.”
The trial is being conducted at 26 U.S.-based study sites consisting of both private ENT clinics and academic medical centers. Dr. Chandrasekhar and Frequency Therapeutics are looking for individuals with sensorineural hearing loss who meet these criteria:
- You are between the ages of 18 and 65 years of age;
- You have a documented medical history of acquired, adult-onset, sensorineural hearing loss; associated with noise-induced SNHL or sudden onset SNHL; and
- You have stable hearing based on a hearing test (audiogram) at least 6 months ago or longer.
Patients with SNHL who are interested in participating in FX-322-208 may visit https://www.clarahealth.com/studies/hearing-study to begin the application process.
About ENT and Allergy Associates, LLP:
ENT and Allergy Associates, LLP (ENTA) has over 220 physicians practicing in 40+ office locations in Westchester, Putnam, Orange, Dutchess, Rockland, Nassau and Suffolk counties, as well as New York City and northern/central New Jersey. The practice sees over 90,000 patients per month. Each ENTA clinical location provides access to a full complement of services, including General Adult and Pediatric ENT and Allergy, Voice and Swallowing, Advanced Sinus and Skull Base Surgery, Facial Plastics and Reconstructive Surgery, Disorders of the Inner Ear and Dizziness, Asthma, Clinical Immunology, Diagnostic Audiology, Hearing Aid dispensing, Sleep and CT Services. ENTA has clinical alliances with Cooperman Barnabas Medical Center, Mount Sinai Hospital, Montefiore Medical Center, Northwell Health, and a partnership with the American Cancer Society. To learn more, visit www.entandallergy.com.
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.
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