Business
Frequency Therapeutics Provides Business Updates and Reports Fourth Quarter and Full Year 2021 Financial Results
Company Reports Steady Enrollment for FX-322-208 Phase 2b Study in Individuals with Sudden and Noise-Induced Sensorineural Hearing Loss; Topline Results
About this update from Korro Bio, Inc.
[{"type":"text","content":"\nCompany Reports Steady Enrollment for FX-322-208 Phase 2b Study in Individuals with Sudden and Noise-Induced Sensorineural Hearing Loss; Topline Results Anticipated in Q4 2022 or Q1 2023\n\nContinued Progress on Second Program for Hearing Restoration, FX-345; Phase 1b Start Anticipated in H2 2022\n\nAdvances Lead Optimization for Remyelination Program in Multiple Sclerosis (MS); Selection of Lead Clinical Candidate in 2022; IND Planned in 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 regenerative potential to restore function, today announced business updates and financial results for the fourth quarter and full year ended December 31, 2021.\n\n“The year ahead has numerous milestones for Frequency and our lead program FX-322, as we plan to complete enrollment and work toward a readout of our FX-322-208 Phase 2b study of individuals with sudden and noise-induced sensorineural hearing loss (SNHL). The design of the study is based on key insights from having built what we believe to be the largest clinical data set in the hearing restoration space, enabling us to hone-in on the severities and etiologies where we have observed FX-322 to have shown clinically meaningful outcomes. We are also aligned with the U.S. Food and Drug Administration on speech perception as the primary endpoint for this study, which we believe increases the likelihood of future technical and regulatory success. We remain on track to report study results by the end of this year, or in the first quarter of next year,” said David L. Lucchino, Frequency’s Chief Executive Officer.\n\nLucchino continued: “2021 was also a highly productive year for our research engine as we worked to expand our clinical pipeline with a second program in hearing restoration. Our new hearing asset, FX-345, has shown pre-clinically to be highly potent, potentially enabling the drug candidate to exert its activity further into the cochlea and treat more and different types of SNHL. We also shared compelling data from our pre-clinical program for remyelination in MS, where we have discovered a novel target and demonstrated a powerful remyelinating effect in vivo. With significant readouts and milestones in the year ahead, we believ...