Frequency Therapeutics (Woburn, Mass.) recently announced data related to its experimental FX-322 drug.
The small Phase 1/2 study, which was published in Otology & Neurotology, found hearing improvements in adults with age-related sensorineural hearing loss.
At present, there are no FDA-approved drugs for preventing or restoring such hearing loss, although administering steroids can facilitate recovery of hearing for some patients with sudden sensorineural hearing loss.
The Frequency Therapeutics study found that participants who received a single dose FX-322 had a statistically significant increase in word recognition. The drug was administered as an intratympanic injection — that is, into the middle ear space. Placebo recipients did not demonstrate meaningful improvement.
Researchers have demonstrated that FX-322 has led to a regeneration of mammalian cochlear hair cells in ex vivo experiments.
Frequency Therapeutics is now evaluating FX-322 in a larger Phase 2a study.
The company has seen its stock price rise 135% over the past year.