REgeneration of inner ear hair cells with GAmma-secretase INhibitors

The REGAIN project aims to develop and test a new drug administered to the ear to treat hearing loss caused by the loss of sensory hair cells in the inner ear.

Welcome to the REGAIN Patient Information page!

This section is designed for patients who are interested in participating in the REGAIN trial.

A drug is in development that may be able to restore hearing loss. The REGAIN study has already shown that the drug is safe and will now continue to test if it affects the ability to hear. The REGAIN trial is currently open to participants in the UK, Greece and Germany (see below for contact details). Compensation for your time and travel will be provided.
We hope that you find the information you are looking for here on the website. If you are interested in taking part, please contact the REGAIN team using the contact details at the bottom of this page.

Why are we doing this study?

The aim of this study is to test a new drug that may be able to treat sensorineural hearing loss. This is the most common form of hearing loss. It can be caused by damage to the hair cells lining the inner ear. When sound waves enter the inner ear, the hair cells move, which sends a signal to the nerve that runs from the ear to the brain. The brain recognises these signals as sounds.
Up until now, damage to the inner ear hair cells has been considered irreversible. Once hair cells become damaged, they will remain damaged throughout a person’s life. Hearing aids can be used for people with hearing loss to amplify sounds to make it easier for damaged hair cells to detect them but there is currently no cure. Recently, scientists have made discoveries, which show that it is possible to regrow hair cells, and potentially restore hearing loss, using a drug known as a gamma secretase inhibitor.

What is the treatment?

The study drug, a gamma secretase inhibitor, is a small chemical compound that may help supporting cells in the inner ear to develop into new hair cells. It has been tested in animals in which it was found to be safe at the doses given. This is the first time the study drug LY3056480 will be tested in people. The study drug is a liquid that must be delivered to the inner ear, through the eardrum using a syringe. This technique is commonly used to deliver other drugs, such as corticosteroids, inside the ear, for example for the treatment of Meniere’s Disease. Each participant will receive an injection in one ear, three times in total by an experienced Ear Nose and Throat surgeon. The same ear will be treated during the study. This will be the ear most affected by your hearing loss. If you feel there is no difference, the study doctor will decide which ear to treat.


Who can take part?

You may be eligible if:

  • You are aged 18-80 years
  • You have lived with the symptoms of hearing loss for less than 20 years
  • You are using hearing aids or they have been previously offered to you
If you also suffer from tinnitus, and this is more of a problem to you than your hearing loss, you will not be eligible to take part.

  • If you live in the UK, please contact the UK REGAIN study team for further information:
    • Royal National Throat Nose and Ear Hospital in London.
      Telephone: 0203 108 9344
      E-mail: ei-regain@ucl.ac.uk
  • If you live in the Greece, please contact the Greek REGAIN study team for further information:
    • 1st Department of Otolaryngology, Hippocrateion Hospital, Athens
      Tel: 213 208 8031
      E-mail: orlregain@gmail.com
  • If you live in Germany, please contact the German REGAIN study team for further information:

If you are not from one of the countries above, please contact Audion Therapeutics BV via info@audiontherapeutics.com

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 634893.