Rinri Therapeutics has received approval to go ahead with its world first trial in humans of cell therapies that aim to regenerate damaged auditory neurons and reverse sensorineural hearing loss.
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Rinri’s clinical trial application for Rincell-1, a first-in-class regenerative otic neural progenitor cell therapy for sensorineural hearing loss (SNHL).
The company, which has been working on the therapy for more than two decades, said in a media release on 1 July 2025, that the potential treatment was a multi-billion dollar market opportunity.
It said clinical proof-of-concept data from the phase I/IIa trial was expected within 12 months of trial initiation.
“While current standard-of-care treatments like cochlear implants help manage the symptoms of sensorineural hearing loss, their effectiveness depends on the integrity of the cochlear nerve,” Rinri said.
“Rincell-1 has been designed to regenerate damaged auditory neurons (nerve cells) for which no treatment currently exists, bringing the potential to transform the lives of people with neural hearing loss and to play a significant role in healthy aging.”
Delivered to the cochlea during surgery
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.
“The study is powered to measure safety and detect significant changes in neural health, as measured by telemetry from Advanced Bionics’ cochlear implant monitoring AIM system, alongside a range of speech perception measures and patient-reported outcomes,” Rinri said.
“Rincell-1 will be delivered to the cochlea during cochlear implant surgery via a novel extension of the current procedure, as previously published in 2024.”
Replace damaged sensory cells
Rinri said on its website that 90% of people with hearing loss have SNHL caused by damage to sensory cells in the inner ear or cochlea.
It said the new “potentially permanent and invisible therapy” is designed to replace these damaged sensory cells by regenerating auditory neurons (nerve cells) which transmit signals from the cochlea to the brain, with the aim of restoring hearing.
The treatment harnesses the potential of stem cells to become any cell in the human body.
“At Rinri we make auditory progenitors from stem cells; these are the early forms of the mature sensory cells in the inner ear,” Rinri said.
“Our data shows that when our therapeutic progenitor cells are delivered to the inner ear, they have the capability to become mature (functional) auditory neurons, re-establish nerve connections in the cochlea and reverse neural hearing loss.”
In preclinical studies, these cells reversed hearing loss and improved the hearing threshold by ~40%, which Rinri said were “strong preclinical results showing safety and effectiveness”.
Dr Simon Chandler, CEO of Rinri Therapeutics, said: “Approval to start our first clinical trial with Rincell-1 in hearing loss is a major milestone and recognition of the potential of our regenerative cell therapy in this area of significant unmet medical need.
“I’d like to thank our staff and partners for their meticulous work towards this achievement, and our investors, Boehringer Ingelheim Venture Fund, UCB Ventures and Pioneer Group, for their support.”
Professor Doug Hartley, CMO of Rinri Therapeutics and chief investigator on the trial, said: “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.”
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