We’re delighted to share that Pioneer portfolio company, Rinri Therapeutics, has secured regulatory approval from the MHRA to begin its first-in-human clinical trial of Rincell-1, a pioneering regenerative cell therapy for sensorineural hearing loss.

This approval marks a significant milestone for Rinri and offers new hope to the millions of people affected by hearing loss around the world.

What Makes Rincell-1 Unique?

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. Rincell-1 has been designed to regenerate damaged auditory neurons, 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.

About the Trial

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. Additional assessments will look at speech perception and patient-reported outcomes.

Professor Douglas Hartley, Rinri’s Chief Medical Officer and Chief Investigator on the trial, reflected on the potential impact: “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.”

A Major Milestone

Sensorineural hearing loss affects millions globally and currently lacks any disease-modifying treatment. Rincell-1 is therefore addressing a multi-billion-dollar market, underscoring both the medical and commercial potential of Rinri’s approach.

Rinri CEO, Dr Simon Chandler, added: “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.”

Pioneer is incredibly proud to support Rinri on this journey and look forward to seeing how Rincell-1 progresses in the clinic. The trial is expected to deliver early data within 12 months of trial initiation and could signal a new era for the treatment of hearing loss.

Find out more about Rinri Therapeutics here.