Latest Trial Underway for Hearing Restoration Drug FX-322

Frequency Therapeutics is conducting a Phase 2b clinical trial to evaluate whether its drug candidate, FX-322, can restore hearing in individuals with sensorineural hearing loss (SNHL) by regenerating sensory hair cells in the inner ear. The medication works by activating progenitor cells to re-grow lost hair cells, which are essential for filtering and tuning sounds. Administered as a gel injected into the eardrum under local anesthesia, FX-322 has shown promise in early studies, with improvements in speech perception reported across three clinical trials. However, a Phase 2a trial comparing FX-322 to a placebo showed no significant hearing improvement, which the company attributes to study design issues rather than the drug's efficacy. To date, five clinical studies have been conducted, and data from early trials were published in *Otology & Neurotology* last year. The company continues to explore the potential of FX-322 for addressing various types and severities of hearing loss.
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Frequency Therapeutics is currently conducting a Phase 2b trial to see if a new drug candidate can restore hearing in people who experience sensorineural hearing loss (SNHL). Frequency Therapeutics is the maker of FX-322, which is designed to regenerate hair cells and restore the hearing loss.

Inside Frequency TherapeuticsInside Frequency Therapeutics

According to the company, FX-322 may improve hearing and specifically a patient’s speech perception, the ability to clarify sounds and understand speech, by regenerating sensory hair cells needed to filter and tune sounds. The medication helps small molecules activate progenitor cells to re-grow these lost sensory cells.

To administer the medication, the doctor numbs the ear and injects FX-322 gel into the person’s eardrum. It’s a common procedure that can be performed by an ear, nose and throat (ENT) doctor.

Testing FX-322

There have already been several studies on FX-322. The company says their data marks the first time in human trials that a therapeutic has shown hearing improvements. It appears to be well-tolerated; no serious adverse effects were reported.

“We have conducted five clinical studies of FX-322 to date,” a Frequency Therapeutics spokesperson tells HearingTracker.com. “With each study, we have added to our understanding of FX-322 and the types and severities of hearing loss where individuals may respond to our drug candidate.”

To date, the company has seen improvement in key measures of hearing function (speech perception) in patients who received FX-322 in three separate clinical trials, the spokesperson said. Last year, data from these early human studies was published in Otology & Neurotology

A subsequent phase 2a clinical trial indicated that there was no improvement in hearing loss when comparing the drug to placebo—which the company ultimately attributed to study design issues, including inconsistent baseline measures and study bias that resulted from information being shared regarding inclusion criteria.

Previous coverage

In February 2021, HearingTracker interviewed Carl LeBel, the Chief Development Officer at Frequency Therapeutics. Listen to learn more.

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