Frequency Therapeutics (Woburn, Mass.) recently announced data related to its experimental FX-322 drug.
The small Phase 1/2 study, 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. However, 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.
FX-322 is a small molecule therapy that targets progenitor cells, which are similar to stem cells in their ability to differentiate into specific cell types. The company has a variety of candidates within its progenitor cell activation platform.
Researchers have demonstrated that FX-322 has led to the 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 draws on the research from MIT professor and prolific inventor Robert Langer and Jeffrey Karp, a professor of medicine at Brigham and Women’s Hospital, Harvard Medical School.
A handful of other companies have explored intratympanic injection to treat hearing loss, tinnitus and other neuro-otologic conditions.
Auris Medical Holding, for instance, has explored the intratympanic use of Sonsuvi (AM-111) for acute inner ear hearing loss and Keyzilen (AM-101) for acute inner ear tinnitus
Otonomy has worked to develop potential intratympanic therapies to treat vertigo associated with Ménière’s disease in a Phase 3 study.
Filed Under: clinical trials, Drug Discovery
