Our Sensorineural Hearing Loss Program

Frequency’s lead asset FX-322 has shown the first-ever statistically significant and clinically meaningful hearing improvement signal in clinical trials, and we are following that signal to deliver FX-322 as the first therapeutic for hearing loss.

Sensorineural hearing loss, or SNHL, is the most common form of hearing loss and results from damage to hair cells in the inner ear or problems with the nerve pathways that convert sound waves from the inner ear to the brain. These sensory hair cells can be lost due to chronic noise exposure, suddenly, as a result of 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 sensory hair cells through activation of progenitor cells already present in the cochlea.

Three clinical studies in which a single dose of FX-322 was administered have shown hearing improvements in measures of speech perception. In addition, in all FX-322 studies, this drug candidate was observed to be well-tolerated with no serious drug-related adverse effects. FX-322 is currently in Phase 2b study.

Our preclinical candidate, FX-345, may enable treatment of different SNHL patient populations.

Beyond our clinical work on FX-322, Frequency is developing a new preclinical candidate to treat sensorineural hearing loss that delivers a regenerative therapeutic that may provide greater coverage and increased potency at the site of action within the inner ear. Known as FX-345, the candidate may enable the treatment of different SNHL patient populations at varying dose levels.

Our Approach to Hearing Restoration

World Health Organization (WHO) estimates show that approximately 1.5 billion people 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 41 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 affect 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.

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