Benzinga | Feb 23, 2021 07:12AM EST

Frequency Therapeutics' FX-322 Data Published In Peer-Reviewed Journal

* Frequency Therapeutics Inc (NASDAQ: FREQ) has announced the publication of its lead candidate FX-322 Phase 1/2 study results in Otology & Neurotology. The data was initially announced in April 2019.

* The data showed hearing improvements in adults with acquired sensorineural hearing loss (SNHL) and the first-known linkage of pharmacokinetics and pharmacodynamics for a potential hearing restoration therapy.

* A single dose of FX-322 demonstrated statistically significant increases in word recognition (WR) and words-in-noise (WIN) scores from baseline to day 90. There were no meaningful changes in the WR and WIN scores of the placebo group.

* FX-322 was also shown to be well tolerated. The publication includes data demonstrating consistent cochlear drug delivery in both preclinical and human studies.

* FX-322 is currently being evaluated in a larger Phase 2a study in 95 patients, with results anticipated later this quarter.

* The Company is conducting Phase 1b studies to evaluate the potential of FX-322 in different patient groups, including patients with age-related hearing loss and severe SNHL. It is also conducting an open-label safety study looking at the administration conditions for FX-322.

* Price Action: FREQ shares closed 5.3% lower at $52.09 on Monday.