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For the last couple of years, all attention has turned to Covid-19 and vaccinations—and for obvious reasons. Now that we are hopefully getting close to the end of the pandemic, it’s time to look into some other important health and biotech developments.

The World Health Organization estimates show that approximately 1.5 billion people have hearing loss globally and more than a billion young people are at risk of hearing loss. According to the United States National Institutes of Health, approximately 90% of those with hearing loss are affected by sensorineural hearing loss (SNHL). Noise exposure is difficult to avoid in modern society and approximately 41 million people in the U.S. may have SNHL.

Unlike other medical conditions, hearing loss is often met with irritation, annoyance and cruel jokes. It’s a meme when grandpa can’t hear what you’re saying and offers an answer different than the question posed. Eye rolls and smirks are commonplace. This wouldn’t be the case for someone who is losing their vision or suffers other maladies.

Growing up in a family with members that had various degrees of hearing loss, you can see the toll it takes on the person and its impact on close relatives and friends. Conversations become uncomfortable. The person with the hearing impairment feels awkward and left out. Oftentimes, they simply give up and withdraw from social activities. This further isolates the person, adding mental health issues on top of the problem. The withdrawal leads to feelings of loneliness, isolation and frustrations. Studies show that the left untreated and remaining outside of social engagements, there may be a higher chance of having dementia or depression.

David Lucchino, Frequency Therapeutics cofounder and CEO, is a life sciences entrepreneur with nearly two decades of executive leadership experience. He played an integral role in launching, building and operating several successful companies in both the biotech and medical device industries.

He’s sympathetic to the plight, as he grew up with his own challenges. Lucchino is dyslexic. He had to overcome childhood dyslexia, in a time when not much was known about it. During that period, teachers were not as focused on the issue. Many educators would contend that a person with dyslexia was either lazy, acting up or not too bright. In grade school, Lucchino’s teachers constantly embarrassed him in front of his classmates for failing his spelling tests. It led him to question his own intelligence. Those were tough times for him, but they taught a young Lucchino the power of tenacity and perseverance.

With this background, it seems natural that he would fight for overlooked people who are marginalized from society, due to their challenges. Despite the odds, he learned how to cope and overcome, becoming a leading biopharma entrepreneur, working to develop the world’s first therapeutic to reverse hearing loss.

In 2014, Lucchino, along with Professor Robert Langer of the Massachusetts Institute of Technology and cofounder of Moderna, along with others, started Frequency Therapeutics. The goal was to pioneer a novel approach to regenerative medicine with a lead program aimed at restoring hearing for the most common form of hearing loss. Frequency is leading a new category of regenerative medicine—one that uses small molecules to “activate” a person’s innate regenerative potential.

People are born with about 15,000 hair cells in the cochlea of each ear. These hair cells are often lost due to noise exposure, as a result of aging, viral infections or exposure to medicines that are toxic to ears. Frequency Therapeutics is one of only a handful of companies around the world that are working to develop a drug to restore lost hearing.

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.

FX-322 is designed to treat the underlying cause of SNHL by regenerating sensory hair cells through activation of progenitor cells already present in the cochlea. Clinical studies, in which a single dose of FX-322 was administered, have shown statistically significant and clinically meaningful improvements in speech perception.

Another candidate, FX-345, may enable treatment of different SNHL patient populations. Beyond its 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. FX-345 may enable the treatment of different SNHL patient populations at varying dose levels.

Carl LeBel, the company’s chief development officer, summarizes the results of those initial trials of FX-322, “In three separate trials, we saw a signal that we’ve defined as improvement in speech perception in patients who have been treated with the drug versus those who were either dosed with a placebo or when compared with their untreated ear”.

Both drug candidates are designed to regenerate lost hair cells, those tiny receptors in the cochlea that convert sound into electrical signals that are then sent to the brain. They die off as we age or they are killed off by noise exposure, certain viruses or ototoxic drugs. The result is SNHL, which is the most common cause of hearing loss. A staggering 10% of the world’s population suffer from SNHL.

LeBel said about the clinical trials, “This is suggesting that the drug could be disease-modifying–so you’re actually correcting the underlying condition.” He added, “We can’t think of a single example where you’ve given one dose of an agent, you produce an effect, and that effect lasts for this long.” With the success of the vaccines, we’ll likely see a resurgence in other treatments for a wide array of health issues.

Source: Forbes

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