Frequency Therapeutics Holds Virtual R&D Event Highlighting Clinical

LEXINGTON, Mass.–(BUSINESS WIRE)–Nov 9, 2021–

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 will host a virtual R&D event. The webcast can be accessed here.

“We look forward to highlighting the extensive data supporting our Phase 2b study (FX-322-208) in patients with sensorineural hearing loss (SNHL), where we have seen clear clinical improvements in speech perception in patient groups that include millions of individuals in the US alone. We have alignment with the FDA on speech perception as the primary efficacy endpoint and will detail the importance of this measure for patients. Our Phase 2b study is enrolling subjects who we believe fit squarely in the range where we have seen clinically meaningful hearing improvements, and we will detail the design of this study,” said David L. Lucchino, Frequency’s Chief Executive Officer.

Mr. Lucchino continued: “We will also unveil two new research programs that demonstrate the potential of our progenitor cell activation (PCA) approach. First, we will introduce FX-345, a new hearing restoration candidate designed for greater distribution through the cochlea, potentially enabling the treatment of expanded SNHL patient populations. We also have a highly promising novel therapeutic approach for multiple sclerosis, remyelinating agents that demonstrate a level of activity that far exceeds alternatives that have been developed to date.”

Event Highlights:

FX-322

• Clinical data review from four completed FX-322 clinical studies, including 169 subjects with a range of hearing loss severities and SNHL etiologies (sudden, noise-induced, age-related).
• Analysis of statistically significant and clinically meaningful patient responses following a single FX-322 administration, establishing the range of severity and etiologies that will be explored in the upcoming FX-322-208 study.
• Review of design of ongoing FX-322-208 study, including use of multiple lead-in hearing measures implemented to reduce study bias and baseline variability.
• Alignment with the U.S. Food and Drug Administration around speech perception measures as a primary efficacy endpoint and the importance of speech perception as the key unmet need for individuals with SNHL.

FX-345

• Introduction of new SNHL investigational therapeutic program, including a more potent GSK3 inhibitor designed to achieve broader exposure of the cochlea.
• Preclinical pharmacokinetic measures and human modeling data, indicating that therapeutically active FX-345 drug levels will be reached in areas of the cochlea corresponding to a wider range of hearing frequencies.
• Potential to benefit an expanded SNHL patient population.
• IND anticipated in Q2…