Business
Frequency Therapeutics Provides Business Updates and Third Quarter 2022 Financial Results
Enrollment Completed for Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss; Readout Expected in Q1 2023 Company on Track for Q4
About this update from Korro Bio, Inc.
[{"type":"text","content":"\nEnrollment Completed for Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss; Readout Expected in Q1 2023\n\nCompany on Track for Q4 Clinical Trial Start of its Second Hearing Restoration Program, FX-345\n\nMultiple Sclerosis Remyelination Program Candidate Advanced to IND-Enabling Studies, with Anticipated 2H 2023 IND Filing\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 business updates and financial results for the third quarter ended September 30, 2022.\n\n“This past quarter has been one of momentum and execution. With the completion of enrollment for the Phase 2b study of our lead therapeutic candidate, FX-322, we are now preparing for a data readout next quarter for what may be the first medicine to treat hearing loss. The FX-322-208 study is designed to show a statistically significant improvement in speech perception, and its pre-specified endpoint would also demonstrate a clinically meaningful outcome for patients. We believe the pending FX-322 data have the potential to support a future marketing application and the design of a subsequent Phase 3 study,” said David L. Lucchino, Frequency’s chief executive officer.\n\nMr. Lucchino continued: “We continue to progress with our second hearing restoration candidate, FX-345, and anticipate initiating a Phase 1b trial in the coming weeks. With a readout planned for the second half of next year, we look forward to exploring the impact of greater cochlear drug exposure and whether that will enable us to expand the SNHL populations we may treat. Finally, our remyelination in multiple sclerosis program is also progressing in IND-enabling studies and we remain on track to move this high potential program toward an IND filing in the second half of 2023. We expect our current cash position will enable us to reach our next set of clinical milestones as we work to continue to advance our pipeline and expand our research focus.”\n\nThe Company will review its FX-322 clinical program and other pipeline activity on a webcast with management and key opinion leaders on Dec. 13, 2022, at 8am ET.\n\nRecent Pipeline Progress and Corporate Highlights\n\nFX-322-208 Phase 2b Stu...