Rinri Gets UK Approval to Begin Clinical Trial for Groundbreaking Hearing Loss Therapy

Rinri’s Clinical Trial Application, a First Approval of the Month

Image Credits: Hearing Health & Technology Matters

Announcement

Rinri Therapeutics, a global company aiming to bring a transformation and development in sensorineural hearing loss (SNHL) with regenerative cell therapy, has received approval from the UK MHRA for a clinical trial application (CTA), a main asset, Rincell-1. The final clinical proof-of-concept data from its first-in-human phase 1/2a trial of Rincell-1, which was a commendable otic neural progenitor cell therapy, is expected in 12 months after the trial.

What Changes and Advancements are Entering the Healthcare Market?

Though the current standard-of-care treatments, such as cochlear implants, have covered the symptoms of sensorineural hearing loss. The impact of the treatment differs according to the integrity of the cochlear nerve. Rincell-1 has been introduced to recover damaged auditory neurons, for which no such treatment has been available. This unmet aspect has a solution in Rincell-1 that is capable of transforming the lives of people with neural hearing loss. It will set the best example of healthy aging.

After landing in three leading hearing research centres in the UK, the open-label trial will be the next clinical stage. Further, the open-label trial will include 20 cochlear implantation patients for hearing loss, 10 patients with severe age-related hearing loss (presbycusis), and 10 patients with postsynaptic auditory neuropathy spectrum disorder (ANSD). In each group, patients will be given a single dose of Rincell-1 in addition to a cochlear implant alone.

Study

The study addresses changes and measures safety in neural health, similarly measuring by telemetry from the advanced bionics cochlear implant monitoring AIM™ system. Rincell-1 will be provided to the cochlea during cochlear implant surgery through its extensive current procedure, also last published in 2024.

Views and Statements

CEO of Rinri Therapeutics, Dr Simon Chandler, said, “The approval to start our first clinical trial with Rincell-1 in hearing loss is a remarkable milestone that has secured a platform to prove the effectiveness of our regenerative cell therapy in the required area. I’m thankful to our partners and staff for their commendable work, also we are pleased with the support of our investors, Boehringer Ingelheim venture fund, Pioneer Group, and UCB ventures.”

CMO of Rinri Therapeutics & Chief Investigator on the trial, Professor Doug Hartley, said, “I understand the situation and the requirement for a therapy for the hearing loss, as I witness it daily. I’m very thrilled to start a clinical trial with Rincell-1, also working with leaders of otologists to discover a new approach to auditory nerve regeneration."