Business
Frequency Therapeutics Provides Business Updates and Reports Third Quarter 2020 Financial Results
Day-90 Analysis of FX-322 Phase 2a Study for Acquired Sensorineural Hearing Loss (SNHL) Planned for Late Q1 2021; End of Study Readout Planned in Late Q2
About this update from Korro Bio, Inc.
[{"type":"text","content":"\nDay-90 Analysis of FX-322 Phase 2a Study for Acquired Sensorineural Hearing Loss (SNHL) Planned for Late Q1 2021; End of Study Readout Planned in Late Q2 2021 \n\nCommenced Phase 1b Study of FX-322 in Patients with Age-Related Hearing Loss; Additional Phase 1b Study in Patients with Severe SNHL to Start Before Year End\n\nCompany Ends Quarter with $224.2M in Cash, Cash Equivalents and Short-Term Investments\n\n WOBURN, Mass.--(BUSINESS WIRE)--\nFrequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage biotechnology company focused on harnessing the body’s innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced business updates and financial results for the third quarter ended September 30, 2020.\n\nThe Company has continued to advance the clinical development program for FX-322, its lead product candidate for the treatment of acquired SNHL, announcing last month a detailed update that includes an upcoming analysis of day-90 data from its Phase 2a study in late Q1 2021. This readout will assess all efficacy and safety endpoints following single or multiple doses of FX-322, or placebo. The Company also reiterated its plan to share end of Phase 2a data in late Q2 2021, evaluating the same metrics as at day-90, as well as the durability of the effect of FX-322 over seven months.\n\nFurther, Frequency is expanding its FX-322 development program to evaluate FX-322’s clinical profile in other SNHL patient types, including those with age-related hearing loss and severe SNHL, in order to identify the broadest population that may benefit from the product candidate. The Company expects to share results from its Phase 1b age-related hearing loss study in Q2 2021 and its Phase 1b severe SNHL study in Q3 2021. SNHL is the most common form of hearing loss, impacting more than 40 million people in the US alone.\n\n“This past quarter we continued to gain momentum, completing study enrollment and moving toward a day-90 readout of the Phase 2a study of FX-322, while expanding our development program by adding additional studies to further our understanding of the potential of FX-322 to help the broadest SNHL patient population. The analysis of day-90 data will enable us to evaluate our key goals for the Phase 2a study and provide a comparison to the hearing improvement signal we observed i...