Frequency Therapeutics Virtual R&D Event to Detail FX-322 Clinical

LEXINGTON, Mass.–(BUSINESS WIRE)–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.

Event Details and Agenda:

The webcast event is scheduled for November 9 from 8 a.m. to 10 a.m. ET, and will include a live Q&A session. Following are the list of management and key opinion leaders that are expected to present and their areas of focus:

• David L. Lucchino, Chief Executive Officer: Strategic Company overview.
• Robert S. Langer, ScD, a Frequency Therapeutics scientific co-founder and MIT Institute Professor: Pioneering a new category in regenerative medicine.
• Carl LeBel, PhD, Chief Development Officer: FX-322 hearing restoration program and the clinical development path.
• Sumit Dhar, PhD, Hugh Knowles Professor of Hearing Science and Associate Provost for Faculty at Northwestern University: Cochlear pathology and the impact of high frequencies on speech perception.
• Kevin Franck, PhD, SVP, Strategic Marketing and New Product Planning: FX-322 clinical data and review of responders.
• Steven D. Targum, MD, Scientific Director, Signant Health: Best-practice approaches for addressing placebo response in clinical trials.
• Christopher…