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Frequency Therapeutics Commences Dosing in its Phase 2a Study of FX-322 for Sensorineural Hearing Loss; FDA Grants FX-322 Fast Track Designation
WOBURN, Mass.--(BUSINESS WIRE)-- Frequency Therapeutics (Nasdaq: FREQ), a clinical-stage biotechnology company focused on harnessing the body’s innate
About this update from Korro Bio, Inc.
[{"type":"text","content":" WOBURN, Mass.--(BUSINESS WIRE)--\nFrequency Therapeutics (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 that dosing has commenced in a Phase 2a clinical study of FX-322, a locally administered investigational drug candidate designed to regenerate auditory hair cells and restore hearing function. The objectives of the Phase 2a study are to further establish the positive hearing signal observed in Frequency’s Phase 1/2 study of FX-322, as well as continue to evaluate safety and define the potential dosing regimen. FX-322 is being developed for the treatment of sensorineural hearing loss (SNHL), the most common type of hearing loss.\n\n\nThe company also announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for FX-322. This designation is intended to facilitate development of new therapies for serious conditions with unmet medical need, expedite review, and enable more frequent engagement between the company and the FDA regarding study planning and design. At present, there are no FDA-approved medicines for SNHL. In a Phase 1/2 study, FX-322 demonstrated a statistically significant and clinically meaningful improvement in key measures of hearing loss, including clarity of sound and word recognition, with no serious adverse events observed.\n\n\n“Starting our Phase 2a study shows continued momentum as we further our understanding of the potential of FX-322, both in measures of loudness and clarity, and work to develop a disease modifying treatment for the millions of people living with sensorineural hearing loss,” said David Lucchino, Chief Executive Officer of Frequency Therapeutics. “We are also pleased that the FDA has granted Fast Track designation for FX-322 and we look forward to continuing our ongoing work with the agency as our study progresses. We want to thank all of the patients participating in this study and the clinicians, audiologists and staff at sites across the U.S. for their efforts and collaboration.”\n\n\nFrequency’s progenitor cell activation (PCA) approach uses small molecules to activate progenitor cells within the body to create functional tissue. Progenitor cells are present throughout the body and programmed to d...