Business
Frequency Therapeutics Provides Business Updates and Third Quarter 2021 Financial Results
Enrollment Underway for FX-322-208 Phase 2b Study in Subjects with Sudden and Noise-Induced Sensorineural Hearing Loss; Aligns with FDA on Speech Perception
About this update from Korro Bio, Inc.
[{"type":"text","content":"\nEnrollment Underway for FX-322-208 Phase 2b Study in Subjects with Sudden and Noise-Induced Sensorineural Hearing Loss; Aligns with FDA on Speech Perception as Primary Endpoint for FX-322 Studies\n\nExpands Pipeline with New Pre-Clinical Program for Hearing Restoration that May Provide Broader Cochlear Exposure and the Potential to Address Expanded SNHL Patient Populations\n\nIntroduces Remyelination Program in Multiple Sclerosis (MS), Sharing In Vivo Data Showing Substantially Greater Activity than Biologic or Small Molecule Comparators\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 business updates and financial results for the third quarter ended September 30, 2021.\n\n“Frequency has made significant operational progress throughout this year, highlighted by the initiation of a Phase 2b study (FX-322-208) of FX-322, our lead program for sensorineural hearing loss (SNHL). We have designed this study following careful analysis of multiple completed FX-322 exploratory clinical studies, and through this work, we’ve increased our understanding of the specific patient etiologies and severities where hearing benefits were observed. We have also reached alignment with the U.S. Food and Drug Administration (FDA) on speech perception as the primary efficacy endpoint that we believe helps de-risk future development activities,” said David L. Lucchino, Frequency’s Chief Executive Officer.\n\n“At our recent R&D event, we detailed results from our completed FX-322 clinical studies, showing all of the data demonstrating a clear signal of clinical benefit in a significant segment of individuals with SNHL. We also showed how the breadth of our clinical efforts informed the inclusion criteria of our ongoing FX-322-208 Phase 2b study. Furthermore, we were excited to introduce two new research programs, the first a pre-clinical development candidate to treat SNHL that can reach deeper into the cochlea and which may provide the opportunity to treat different patient populations. The second is a novel candidate for remyelination in MS that has shown significant remyelinating effect in vivo and has the potential to provide a highly differen...