LEXINGTON, Mass.– Frequency 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 that the Company will be hosting a virtual R&D event on November 9, 2021.
At the event, Frequency’s clinical leaders will provide a detailed review of data from nearly 170 subjects dosed with FX-322. A rigorous statistical analysis of these clinical data uncovered the patient populations most likely to benefit from FX-322 and these patients are now being recruited in the Company’s recently initiated FX-322 Phase 2b study (FX-322-208). Key opinion leaders in auditory science and clinical study design will provide insights on FX-322 clinical results and the strategy supporting the new FX-322-208 trial.
The FX-322-208 study is designed to demonstrate improved speech perception in an enriched population of individuals with SNHL where statistically significant and clinically meaningful hearing improvements in speech perception were observed in prior trials. The U.S. Food and Drug Administration (FDA) recently agreed with speech perception as the primary endpoint for FX-322 development, including for the FX-322-208 study and all future FX-322 studies.
In addition to discussing clinical development advances, the company will unveil two new advanced research programs:
- A new candidate to treat sensorineural hearing loss that delivers a regenerative therapeutic that may provide greater coverage and increased potency at the site of action within the inner ear, that may enable the treatment of different SNHL patient populations at varying dose levels and;
- A novel approach for remyelination in multiple sclerosis, including in vivo findings showing potent biological activity and a comparison of this program to other leading approaches.
