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Frequency Therapeutics Announces First Subject Dosed in FX-322 Phase 2b Acquired Sensorineural Hearing Loss (SNHL) Study and FDA Agreement on Speech Perception as Primary Endpoint
FX-322-208 is a Randomized, Placebo-Controlled Study to Evaluate Hearing Improvement in Subjects with Acquired SNHL Company to Host R&D Event on November 9th
About this update from Korro Bio, Inc.
[{"type":"text","content":"\nFX-322-208 is a Randomized, Placebo-Controlled Study to Evaluate Hearing Improvement in Subjects with Acquired SNHL\n\nCompany to Host R&D Event on November 9th to Provide Detailed Review of Completed FX-322 Clinical Studies Supporting FX-322-208 Inclusion Criteria and Study Design \n\n 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 announced that the first subject has been dosed in a new FX-322 Phase 2b study (FX-322-208) being conducted in a refined population of individuals with SNHL.\n\nFX-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 SNHL. The study’s primary endpoint is speech perception, a measure of sound clarity and understanding speech. The Phase 2b study’s inclusion criteria are designed to enroll subjects with the same hearing loss severities and etiologies as those subjects in which statistically significant improvements in speech perception were observed in prior FX-322 clinical studies. FX-322-208 will include subjects with hearing loss associated with either noise-induced or sudden SNHL.\n\nThe U.S. Food and Drug Administration (FDA), in a recent Type-C meeting with the Company, agreed that speech perception is an acceptable primary efficacy endpoint. A variety of other listening tests, including multiple measures of speech perception and pure tone thresholds, will also be assessed.\n\n“The FX-322-208 Phase 2b study incorporates learnings from all of our prior studies, enabling us to identify targeted patient populations and prior responder groups for evaluation. We are testing FX-322 in subjects with hearing loss severities and etiologies where we have seen improvements in past trials. We have also applied key additional design elements to the study to mitigate potential bias and help ensure the consistency of baseline hearing assessments,” said David L. Lucchino, Frequency’s Chief Executive Officer. “Moreover, we are very pleased to have obtained alignment with the FDA on speech perception as the primary endpoint for our upcoming studies, given the important need for treatmen...