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Frequency Therapeutics Announces First Patient Dosed in Phase 1b Study of FX-345, the Company’s Second Therapeutic Candidate for Sensorineural Hearing Loss
Regenerative Treatment Designed to Increase Drug Exposure Through the Cochlea; Study Results Expected in H2 2023 Frequency’s Lead Hearing Program, FX-322, on
About this update from Korro Bio, Inc.
[{"type":"text","content":"\nRegenerative Treatment Designed to Increase Drug Exposure Through the Cochlea; Study Results Expected in H2 2023\n\nFrequency’s Lead Hearing Program, FX-322, on Track for Phase 2b Topline Results in Q1 2023\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 potential to restore function, today announced that it has dosed a first patient in the Phase 1b study of FX-345, the Company’s second hearing restoration candidate for sensorineural hearing loss (SNHL).\n\nFX-345 is a combination of two small molecules and, similar to Frequency’s lead hearing candidate FX-322, is designed to restore inner ear cells needed for hearing. However, FX-345 includes a more potent GSK3 inhibitor, a new chemical entity that may enable targeted drug exposure further into the cochlea. Future clinical studies will determine whether greater cochlear drug exposure can address additional populations of individuals with SNHL.\n\n“Advancing FX-345 to the clinic is an exciting milestone as we further our pioneering work to develop regenerative therapeutics for hearing loss. By expanding our hearing pipeline, we hope to better understand the breadth of SNHL types and severities we may be able to treat, and we look forward to FX-345 Phase 1b study data in the second half of next year,” said Frequency’s Chief Executive Officer David L. Lucchino. “I am pleased with our team’s work to advance small molecule drug delivery, enabling us to explore the impact of reaching further into the cochlea to build upon our understanding of how our approach may restore human hearing.”\n\nThe Phase 1b trial, FX-345-101, is a prospective, randomized, single-blind, placebo-controlled, multicenter study to evaluate the safety of FX-345, administered as a single intratympanic injection, in approximately 36 adults aged 18-67, with adult-onset acquired SNHL. The study is divided into two cohorts, with an initial safety cohort of nine subjects designed to provide a rapid assessment of safety and drug exposure. Pending favorable safety results, a second cohort of 27 subjects will be dosed to continue the safety assessment and evaluate whether FX-345 favorably improves measures of auditory function. Within each cohort, subjects will be random...