Frequency Therapeutics on a mission to restore hearing loss

$FREQ

Prevalence of hearing loss

About 800 million people suffer from hearing loss worldwide. More than 90% of them have sensorineural hearing loss (SNHL). Sensorineural hearing loss means hearing loss due to damaged hair cells in the inner ear. These patients have normal hearing nerves. About 59 million people in the United States have SNHL. With the advent of new technological advancements and our present lifestyles, the hearing loss patients population is expected to grow due to recreational noise exposure upto 1.1 billion between ages 12 to 35.

US prevalence of hearing loss is estimated to grow to more than 78 million patients by 2025. Company estimates the prevalence of patients with moderate to severe SNHL to be about 30.3 million.

It is very interesting to note that untreated hearing loss is associated with a 50% increase in dementia and a 40% increase in depression. 

Biology of hearing

When sound is generated, it travels in air via vibrations. These vibrations enter our ear canal and vibrates the eardrum. That eardrum with help of other inner ear bones transmits vibration to the inner ear called Cochlea. The cochlea is a fluid filled snail like structure. Its inner surface is lined with hair cells that when activated by movement of fluids generate electrical signals that get transmitted to the brain via the auditory nerve. Thus sound is heard. When patients have SNHL; those hair cells are damaged.

source:Teded (The Science of Hearing | The Kid Should See This)

Please watch this video to understand hearing:

Humans are born with 15000 hair cells in the cochlea in each ear.  These hair cells are lost progressively due to noise exposure in a variety of settings or as a result of aging which ultimately leads to SNHL.

What are the treatments available for SNHL ?

The only available treatment for chronic SNHL loss is hearing aids. There is no treatment to modify or cure underlying biology. In extreme cases cochlear implants are used. There is no approved drug therapy.

Disadvantages of hearing aids

The hearing aids amplify sounds. Since hair cells are damaged; the quality of sound is still poor.  Hair cells can recognize a wide variety of frequencies and modulate transmission of these impulses so hearing is always clear but hearing aids can’t do that. There is always a stigma associated with hearing aids. Not to mention, ongoing maintenance costs.

Cochlear Implants:

It requires an invasive, costly surgical procedure but still comes with an external microphone, sound processor and transmitter system and still doesn't mimic natural hearing.

With this background, I am happy to introduce you Frequency Therapeutics which is trying to solve the problem of sensorineural hearing loss using regenerative therapy

Frequency Therapeutics

Frequency Therapeutics is a clinical-stage biotechnology company that is trying to treat hearing loss by utilizing our own body’s innate biology to repair or reverse the damage.

The company is trying to develop a progenitor cell activation platform (PCA) where in small molecule therapeutics designed to activate already dormant progenitor cells to create healthy organs.

The company is targeting treatment of SNHL as an initial focus. 

FX 322 lead candidate

Many vertebrates like birds and reptiles can regenerate their hair cells spontaneously, mammals do not. In mammals progenitor cells can produce hair cells persist during adulthood but remain dormant.

FX 322 is small molecule therapeutics that can be administered in the office setting with needle and syringe into the middle ear. The therapeutics then diffuse and goes into the inner ear and starts activating progenitor cells with missing hair cells.

The picture above shows the inside of inner ear, the normal sensory hair cells with sensory hairs and other areas of missing hair cells.

The picture above shows that FX 322 acts on progenitor cells in cochlea and helps them grow hair cells.

This is very fascinating science which I believe will have broad implications in potentially treating a variety of diseases in other organs without self healing or regeneration capacity.

The company announced publication of Phase 1 and 2 data showing hearing improvements in acquired sensorineural hearing loss patients receiving FX-322. The company expects interim FX-322 Phase 2a study data later 1Q of 2021.https://investors.frequencytx.com/news-releases/news-release-details/frequency-therapeutics-announces-publication-phase-12-data The present study showed statistically significant increase in word recognition and words-in-noise (WIN) scores. There were no meaningful changes in the placebo group. This is the first study to show a potential therapeutic solution to address word recognition and understanding in hearing loss patients.

Why I am bullish on this company

After my due diligence I realized that there is no effective treatment for chronic sensorineural hearing loss. Even I was under the impression that hearing aids would solve most of the problem. But, I came to know that hearing aids only amplify the sounds but will not make words more clear. Still patients with hearing loss have disability understanding and comprehending speeches. FX 322 is only the potential treatment that addresses the biology and regenerate hair cells thus solving the problem where it is located in the human body. The findings of phase II study are very promising and FX 322 is emerging as a strong candidate. Since there is no effective therapeutics, any medicine that works will be approved. The bar for FX 322 is very low. WHO estimates 1.1 billion people will have some form of hearing loss between ages 12 to 35 and the company is trying to help large unmet needs of mankind.

Long $FREQ. It is a very small position for me. 

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