A new cell therapy that could repair damage to the auditory nerve and improve hearing could be transformative for millions of people with hearing loss, with clinical trials starting in the next two years.
The impact of hearing loss
Hearing loss affects 12 million people in the UK, and increases as we get older, affecting more than 40% of over 50s and rising to 70% of over 70s. People with hearing loss often experience communication barriers, and are less likely to be employed than the general population. They are twice as likely to experience mental health problems, including depression, and can be up to five times more likely to develop dementia. 1.2 million adults in the UK have hearing loss severe enough that they would not be able to hear most conversational speech.
Pioneering research
The groundbreaking work of Sheffield-based Rinri Therapeutics was founded on pioneering research into regenerative cell therapy, led by Professor Marcelo Rivolta at the University of Sheffield. Funded by RNID, his laboratory team discovered how to turn pluripotent stem cells into specialised auditory nerve cells that carry information to the brain. These cells were able to reverse hearing loss, resulting in approximately 40% improvement in the hearing threshold.
Rinri’s work is now at an advanced stage of preclinical development and the company hope to start clinical trials in the next two years with patients with deficiencies in the auditory nerve, such as those with severe-to-profound age-related hearing loss. Rinri’s cell therapy, Rincell-1, is for patients with auditory neuropathy, a form of hearing loss which occurs when sounds become disrupted as they travel to the brain. Rinri says patients with auditory neuropathy make up 25% of the sensorineural hearing loss community.
Clinical trials
Patients will receive Rincell-1, which will regenerate auditory neurons and re-establish the transmission of nerve signals from the inner ear to the auditory centres of the brain to reverse hearing loss. If clinical trials are successful, Rincell-1 could be available as a treatment to people with hearing loss within the next 5-10 years.
To measure if their cell therapy is effective, in First-in-Human trials Rinri proposes administering Rincell-1 with cochlear implants – devices designed to bypass damaged hair cells and directly stimulate auditory neurons. Cochlear implants can act as a recording sensor to pick up signals made by the cochlea as it passes sound information to the auditory nerve, so this will allow researchers to record objective measures of cochlear health, rather than only relying on subjective measures like speech recognition.
Professor Marcelo Rivolta, Founder and CSO of Rinri Therapeutics, said:
“It is well recognised that hearing loss significantly impacts quality of life, affecting 1 in 5 adults in the UK. A biological solution that can restore hearing significantly would be transformative to people with hearing loss, and we look forward to taking the next step by starting clinical trials in 2025.”
Dr. Simon Chandler, CEO of Rinri Therapeutics, said:
“The number of people with hearing loss is staggering, on a par with the global incidence of diabetes and osteoarthritis, yet there is currently no treatment available to restore hearing or prevent hearing loss. At Rinri, we envisage a world where hearing loss can be restored, reconnecting people with the world around them. Our mission is to realise the potential of cell therapy to treat hearing loss for millions of patients around the world.”
Ralph Holme, Director of Research and Insight at RNID, said:
“RNID and our supporters are really excited about Rinri’s work, which could result in a life-changing treatment for millions of people with age-related hearing loss caused by damage to the auditory nerve.
“Whilst devices like hearing aids and cochlear implants can be hugely beneficial to people with hearing loss, they are not a complete solution and people still face significant barriers in their daily lives.
“For years, people with hearing loss have dreamed of a future where treatments to restore hearing will be available, and so it’s exciting to see therapies like this which could offer hope to so many approaching clinical trials. Thank you to our supporters who have helped fund this important work, which could benefit millions in the future.”
Jennifer Macintosh, 73, from Brighton, has hearing loss. She said:
“A treatment for hearing loss would make a great difference because no more hearing aids, I’d be able to take part in larger family gatherings, to take part in more social activities, when I’m in gym classes I would be able to join in the laughter and banter instead of just standing there wishing I could.
“To start at the beginning of an exercise instead of one movement behind because you copy what is happening, to be able to go to any restaurant without worrying about noise, hear a theatre production without it being hit and miss. Also, perhaps more importantly, hear with clarity when you have medical appointments and dental treatment what is going on.”
This research was presented at the Hearing Therapeutics Summit on 2 September 2023, organised by RNID with the UCL Ear Institute and National Institute of Health Research.