A new drug being tested by researchers across seven different countries could well be a treatment for hitherto permanent hearing loss.
The drug is a ‘gamma scretase inhibitor’, which is a small compound that may help supporting cells in the human cochlea to develop into new hair cells. Hair cells in the cochlea are the magical instruments that help convert the mechanical sounds into electric pattern. These electric patterns travel up to the brain via hearing nerve. Brain deciphers the pattern for us to make sense of sound and words. Cochlea is richly supplied with supporting cells around the hair cells. Sensoryneural hearing loss is a result of damage to these hair cells. If we can make functional hair cells from supporting cells, that will restore the hearing function.
The researchers have been able to prove the regeneration of functional hearing cells in the animal models already. The next phase led to human trials. However, what is the single most important factor in trailing a new drugs in human? Of course it is the safety and tolerability of the new chemicals in the human body. We would not want more harm than benefit, will we!
So, the phase 1 trial was directed at safety and tolerability and researchers across UK, Germany, and Greece have reported positive results in the safety domain on 40 patients that the drug was tried on. The official website reports: “Phase I clinical trial demonstrated that trans-tympanic injection (3 administrations, one week apart) at the highest dose of 250 micrograms of LY3056480 was safe and well tolerated”
So, the drug in development is well tolerated. The next step to test is- if it can improve the ability to hear in human subjects. For this, the researchers are now looking for individuals with permanent hearing loss to participate in the study. In ‘Phase 2’ of the trial, the 40 participants will receive three injections of the study drug into the inner ear, through the eardrum, using a syringe. This is a safe technique and is commonly used to deliver other drugs 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 experiences Ear, Nose, and Throat Surgeon.
Who can take part?
You may be eligible if: 1. You are aged 18-80 years 2. You have lived with the symptoms of hearing loss for less than 20 years 3. 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
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
If you live in Germany, please contact the German REGAIN study team for further information:
University of Tübingen
If you are not from one of the countries above, please contact Audion Therapeutics BV via firstname.lastname@example.org
There are over 360 million people with hearing loss worldwide. Regain Your Hearing Consortium is an international consortium of 7 partners has been awarded a €5,8 million European Commission Horizon 2020 grant to develop and test a new drug to treat hearing loss caused by the loss of sensory hair cells. Visit the official website and other news here: https://www.regainyourhearing.eu/trial/
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