BioTuesdays

Frequency Therapeutics gets FDA fast track designation for FX-322; begins Phase 2a study dosing

In addition to receiving FDA fast track designation for FX-322, Frequency Therapeutics (NASDAQ:FREQ) initiated dosing in a Phase 2a clinical study of the drug candidate for the treatment of sensorineural hearing loss (SNHL). 

SNHL, the most common type of hearing loss, is caused by damage to the hair cells in the inner ear or the nerve pathways from the inner ear to the brain. FX-322 is designed to restore hearing function by regenerating auditory hair cells. 

The study is expected to enroll some 96 adults with stable SNHL at 12 U.S. sites. The trial’s key efficacy endpoints are word recognition, words-in-noise, and standard pure tone audiometry.

“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,” CEO David Lucchino said in a statement.

Frequency expects topline data from the study in the second half of 2020.

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