LONDON, UNITED KINGDOM — Researchers at UCLH’s Royal National Throat Nose and Ear Hospital (RNTNEH) and UCL Ear Institute are leading a drug trial aimed at regenerating the sensory receptors (hair cells) in the inner ear. While long thought to be irreversible, past animal studies have indicated that these cells can be regenerated through the use of a small molecule substance known as a gamma-secretase inhibitor.
Currently, there are no drugs available to treat loss or damage of the the hair cells in the inner ear, referred to as sensorineural hearing loss. It is estimated that approximately 90% of all hearing losses, including loss that occurs later in life, is sensorineural in nature.
REGAIN Drug Trial to Restore Hearing
Researchers at RNTNEH and the UCL Ear Institute are now leading a trial, which is being undertaken by the REGAIN (Regeneration of inner ear hair cells with gamma-secretase inhibitors) consortium made up of partners in the Netherlands, UK, Greece, Germany and Denmark, in order to test a drug in patients with hearing loss based on these studies.
“We are proud to be part of the REGAIN consortium and to be leading on translating this scientific breakthrough into a treatment that may improve people’s hearing and lives.”
–Professor Anne Schilder, director of evidENT at the UCL Ear Institute
For ‘phase 1’ of the REGAIN trial, which took place throughout 2018, the clinical research team at RNTNEH gave the drug via injections to the ear to 15 patients with mild to moderate sensorineural hearing loss, to test the safety and tolerability of the drug.
Researchers at UCLH and UCL – along with sites in Germany and Greece – are now moving on to the next stage of the REGAIN clinical trial. The ‘Phase 2 study’ will test the efficacy of the drug in 40 adults with mild to moderate adult-onset sensorineural hearing loss.
Current treatments – hearing aids and cochlear implants – work by amplifying the sound waves entering a person’s ear, but have no impact on the underlying physical problems in the ear responsible for hearing loss, such as hair cell loss.
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.
According to the announcement, patients interested in participating in phase 2 study of the REGAIN clinical trial in the United Kingdom, at UCLH and UCL, can visit www.regainyourhearing.eu.
Patients are eligible if they meet the following criteria:
- Aged 18-80 years
- Have lived with the symptoms of hearing loss for less than 20 years
- Have bilateral, symmetrical hearing loss
- Use hearing aids or have been previously offered hearing aids