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Drug Shows Promise In Restoring Hearing…

Frequency Therapeutics recently announced data related to its experimental FX-322 drug. This drug shows promise in restoring hearing for people suffering from mild to moderately severer sensorineural hearing loss. The first phase of a small study, published in Otology & Neurotology, found hearing improvements in adults with age-related sensorineural hearing loss. Currently, there are no FDA approved drugs available for preventing hearing loss. However, the use of steroids can help recover hearing in some people who experience sudden hearing loss.

The Drug

FX-322 is a small molecule therapy that targets progenitor cells. These cells are similar to stem cells in regards to their ability to differentiate into specific cell types. Researchers have demonstrated that in ex vivo experiments, FX-322 has led to the regeneration of cochlear hair cells, which are the primary sensory cell for detecting sounds.

The Results

The drug was administered as an Intratympanic injection — into the middle ear space. The Frequency Therapeutics study found that participants who received a single dose FX-322 had a statistically significant increase in word recognition. Placebo recipients did not demonstrate meaningful improvement.

Phase 2

After showing promise in phase 1, phase 2a of the study unfortunately showed that four dosing regimens of its hearing loss treatment did no better than placebo. The company designed the phase 2a trial to learn whether repeat dosing could boost the effects of FX-322, a medicine that harnesses the body’s healing abilities. It works by triggering dormant progenitor cells in the ear to spur the growth of new hair cells that sense and translate sound. They are, however, looking on the bright side and are hoping to do further research in the future to find the optimal way in which the FX-322 drug works.

“But it did give us the confidence to move forward down a path that looks like a single injection. As we work through some bias issues, I think we’re going to be well-positioned,” said Carl LeBel, Ph.D., Frequency’s chief development officer.

“It’s fair to say we have more phase 2 work to do. Some of these things we uncovered out of the four-injection study, we really want to home in on as we begin to think about what a pivotal trial design will look like in the future,” he added.