Rinri Therapeutics received approval from the UK MHRA to begin its first-in-human clinical trial for Rincell-1, a regenerative cell therapy designed to treat sensorineural hearing loss (SNHL). The Phase I/IIa trial will include 20 patients undergoing cochlear implantation, some with auditory neuropathy and others with age-related hearing loss, to evaluate Rincell-1’s safety and efficacy. The company anticipates clinical proof-of-concept data within 12 months of trial commencement.

This trial represents a significant advancement in hearing loss treatment. Current options, such as cochlear implants, only address the symptoms and rely on existing nerve function. Rincell-1, however, targets the underlying cause of neural hearing loss by regenerating damaged auditory neurons, offering a potential disease-modifying treatment where none currently exist. This innovative approach could drastically improve the quality of life for millions affected by SNHL, a condition currently impacting over 7 million people globally. The potential for Rincell-1 to address this significant unmet medical need also represents a substantial market opportunity.

The trial will be conducted across three UK hearing research centers. It will evaluate the impact of Rincell-1 alongside standard cochlear implantation. Researchers will use Advanced Bionics’ cochlear implant monitoring system to measure neural health changes. They will also assess speech perception and collect patient-reported outcomes. Rincell-1’s delivery method, a novel extension of the existing cochlear implant procedure, was previously published in 2024. Financial backing for Rinri Therapeutics comes from Boehringer Ingelheim Venture Fund, UCB Ventures, and Pioneer Group.

The MHRA approval allows Rinri Therapeutics to move forward with a potentially transformative treatment for SNHL. Positive results from this trial could pave the way for a new class of therapies targeting the root cause of neural hearing loss and significantly impact the lives of those affected by this prevalent condition. It could also establish Rinri as a leader in the regenerative cell therapy space for hearing loss, opening a multi-billion dollar market.

Source link: https://www.globenewswire.com/news-release/2025/07/01/3108053/0/en/UK-MHRA-Approval-Received-for-First-In-Human-Trial-of-Rincell-1-a-First-In-Class-Regenerative-Cell-Therapy-for-Sensorineural-Hearing-Loss.html

Jon Napitupulu
+ posts

Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.