Our Sensorineural Hearing Loss Program

Sensorineural hearing loss, or SNHL, is the most common form of hearing loss and results from damage to the hair cells in the inner ear or problems with the nerve pathways that convert sound waves from the inner ear to the brain. These hair cells can be lost due to chronic noise exposure, aging, certain viral infections or exposure to drugs that are toxic to the ear.

The human ear does not spontaneously restore lost or damaged hair cells, making hearing loss a permanent condition. Today, there are no FDA-approved therapeutic options for SNHL.

FX-322 is designed to treat the underlying cause of sensorineural hearing loss (SNHL) by regenerating hair cells through activation of progenitor cells already present in the cochlea.

In a Phase 1/2 study, FX-322 demonstrated a statistically significant and clinically meaningful improvement in key measures of hearing loss, including clarity of sound and word understanding. In addition, FX-322 was observed to be well-tolerated with no serious adverse effects. FX-322 is administered locally by an ear, nose, and throat specialist, using a standard in-office procedure.

In 4Q 2019 we commenced a Phase 2a study of FX-322.

Frequency’s Approach to Regenerating Lost Cochlear Hair Cells

World Health Organization (WHO) estimates show that approximately 800 million adults have hearing loss globally and has reported that today more than a billion young people are at risk of hearing loss. According to the US National Institutes of Health, approximately 90 percent of those with hearing loss are affected by sensorineural hearing loss. Noise exposure is difficult to avoid in modern society and, based on our estimates, we believe that 59 million people in the United States alone may have SNHL, based on numbers of diagnosed and undiagnosed.

There are also further direct and indirect impacts on individuals suffering from SNHL. Hearing loss can profoundly effect an individual’s ability to participate in social interactions, which can lead to feelings of loneliness, isolation, and frustration. Untreated hearing loss is also correlated with dementia and depression.