Over 20 treatments to restore or protect hearing are currently in clinical trials. If they are successful and pass all three stages of these trials, the way we manage hearing loss could change significantly. Our Translational Research Manager, Dr Carina Santos, tells us the good news.
The World Health Organization (WHO) released a report on deafness and hearing loss earlier this year showing some alarming numbers. Currently in the world, there are 466 million people with disabling hearing loss and 1.1 billion young people (12-35 years old) are at risk of losing their hearing due to recreational noise (e.g. listening to loud music through headphones).
Compared to cancer and dementia, the number of people affected by hearing loss is significantly higher: 50 million people have dementia worldwide and 8.8 million people died from cancer in 2015 (WHO).
Last year, the prestigious medical journal, The Lancet, published an article reporting that hearing loss is one of the top risk factors for dementia (see our blog post about this study). Despite the evidence that the number of people with hearing loss is increasing and that hearing loss can have serious consequences for people’s quality of life, there are currently no available treatments to protect or restore our hearing.
Some good news
Over 20 treatments for hearing loss and tinnitus are currently being tested in clinical trials. The clinical trial stage comes after these medicines are shown to protect or restore hearing in animal models. Being in clinical trials means that they are now being tested in people to assess how effective and safe they are. All treatments have to be tested in three phases of clinical trials before being approved and made available to everyone.
- Phase 1 makes sure that the medicine is safe to be used in people.
- Phase 2 tests if the medicine is effective, meaning that it prevents or treats the condition, and establishes the dose at which it needs to be given to people to be effective.
- Phase 3 is usually a trial that involves a larger number of people, confirms the effectiveness and safety of the medicine, identifies any side effects, and compares its benefits in relation to its risks.
Treatments that regenerate hearing
Last month, Frequency Therapeutics announced that its regenerative therapy for hearing loss had progressed to Phase I/II of clinical trials. Frequency Therapeutics is a US-based company developing a drug called FX-322. This drug has the potential to repair the damaged inner ear by regenerating the hair cells and restoring hearing. Hair cells transform sound into electric signals that the brain understands and are frequently damaged or lost in sensorineural hearing loss. At the end of 2017, Frequency Therapeutics finished an initial test in a small group of people showing that the drug was safe. They are now progressing to test how well the drug restores hearing, and how safe it is, in a larger number of people.
The REGAIN consortium, an international consortium supported by EU funding is also testing a drug that works as a chemical ‘switch’ to produce new hair cells from other cells in the inner ear, called ‘supporting cells’. Their Phase I clinical trial is taking place in the UK, at the UCL Ear Institute and Royal National Throat Nose and Ear Hospital. Read details about this study.
Novartis, one of the biggest global pharmaceutical companies, is also undergoing a Phase I/II trial with a gene therapy, CGF166, which aims to activate supporting cells to generate new hair cells and restore hearing.
If these treatments prove to be effective, they will have the potential to be used in several different types of sensorineural hearing loss.
Treatments that prevent hearing loss
Sensorion, a French company that is developing several treatments for inner ear disorders, vertigo and tinnitus, has finished a Phase I trial for sudden sensorineural hearing loss and will soon progress to a Phase II clinical trial. Sudden sensorineural hearing loss, also known as sudden deafness, is characterised by a rapid loss of hearing that can happen at once or over a period of several days. Most of the time the cause is unknown, but infectious diseases, head injury, or other disorders can trigger this condition. Sensorion’s drug will be tested in hundreds of people in different regions of the world. Their drug (SENS-401) aims to stop the progression of hearing loss by preventing damage to the hair cells and nerve cells that connect the ear to the brain.
An increasing number of treatments that have not yet reached clinical trials are also under development. Both private and public investors have been increasing their financial support to these treatments, which will help to make them available to patients faster. For instance, Decibel Therapeutics, a US-based company dedicated to the discovery and development of medicines for hearing loss, raised $55 million in June 2018 from private investors to develop treatments for hearing disorders. Otomagnetics is a US-based company that is developing a more efficient way of delivering treatments to the hard-to-reach inner ear by using a magnetic injection system. At the end of last year, Otomagnetics was awarded a $2.3 million grant from the National Institutes of Health. Prior to this, in 2013, we awarded Otomagnetics a Translational Research Grant of £300,000. Our funding was crucial in enabling the company to carry out initial testing of their magnetic injection system. This was necessary for them to obtain the larger follow-on funding, which will be essential to progress their system to be used in people.
The concerted effort of researchers, industry, funding bodies like Action on Hearing Loss, and private investors has been crucial for increasing the number of treatments currently being tested for hearing loss and tinnitus. The future looks promising and we are all eagerly waiting to see these treatments pass the different phases of clinical trials and bring everyone the opportunity to protect and restore their hearing.
You can read detailed information about the clinical trials on the links below:
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