First-in-human trial approved for Rincell-1 therapy to regenerate damaged auditory neurons

Rinri Therapeutics has received approval from the UK’s Medicine and Healthcare products Regulatory Agency (MHRA) to begin its first-in-human clinical trial, a major step towards transforming the treatment of sensorineural hearing loss with a regenerative cell therapy.

Rincell-1, the therapy developed by this leading University of Sheffield spin-out company, has been designed to regenerate damaged auditory neurons, for which no treatment currently exists. Taking place at three leading hearing research centres in the UK, the randomised open-label trial will involve 20 patients undergoing cochlear implantation for hearing loss, 10 with postsynaptic auditory neuropathy spectrum disorder (ANSD), and 10 with severe-to-profound age-related hearing loss (presbycusis). Within each group, patients will be randomly assigned to receive a single dose of Rincell-1 in addition to cochlear implantation or cochlear implantation alone.

“Working daily with individuals suffering from hearing loss, I know how devastating it can be, and the acute need for a therapy to change the disease course. It’s very exciting to be starting a clinical trial with Rincell-1, working with otologists across the world to develop this promising new approach to auditory nerve regeneration,” said Professor Doug Hartley, CMO of Rinri Therapeutics & Chief Investigator on the trial.

Rinri Therapeutics’ cell therapies pack a multi-billion dollar sales potential. The company is headquartered in Sheffield, UK, and backed by UCB Ventures, Boehringer Ingelheim Venture Fund and Pioneer Group.  Source: University of Sheffield