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Frequency Therapeutics Shares Results from FX-322-113 Severe Sensorineural Hearing Loss Study Showing Speech Perception Improvements in Noise
LEXINGTON, Mass.--(BUSINESS WIRE)-- Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing
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[{"type":"text","content":" LEXINGTON, Mass.--(BUSINESS WIRE)--\nFrequency 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 shared the results from its FX-322-113 study, a placebo-controlled trial evaluating the administration of FX-322 in subjects with severe sensorineural hearing loss (SNHL). In the study, FX-322 was associated with a hearing signal as shown by improvements by four subjects in a sentence-in-noise test.\n\nFX-322-113 is a double-blind, placebo-controlled Phase 1b study designed to assess the local and systemic safety of a single dose of FX-322, and to evaluate hearing responses in a cohort of individuals with severe SNHL (pure tone average deficit between 71-90 decibel (dB) hearing level), a patient population that may have considerable damage to their inner ears and where cochlear implants may be the only potential intervention to improve hearing. Subjects were randomized 4:1 and received either FX-322 or placebo in one ear. Safety, otologic and audiologic assessments were conducted at days 30 and 90 following administration of FX-322 or placebo.\n\nTo gain a more comprehensive understanding of the potential impact of FX-322 in this population, the Company evaluated hearing function using multiple tests of speech perception in both quiet and noisy backgrounds, including the Bamford-Kowal-Bench Sentence-in-Noise exam (BKB-SIN). BKB-SIN is a validated test designed for severe SNHL populations (including cochlear implant patients), measuring the change in signal-to-noise ratios (SNR) required for a subject to correctly repeat words in a sentence.\n\nIn the FX-322-113 study, BKB-SIN test improvements were observed in four subjects, all of whom exceeded the 95 percent critical difference of 3.1 dB SNR, with two subjects showing a 6 dB response. A single placebo patient had a 3.6 dB change. In the study, subjects did not show substantial changes in speech perception measures in quiet, the safety profile in the study was favorable and there were no treatment-related serious adverse events reported.\n\n“Given the level of cochlear damage, identifying single words in any audiologic test can be very challenging for these individuals. Response to the BKB-SIN test and a 6 dB improvement in the signal-to...