Public Funding for Rinri Therapeutics Limited

Over 400m people have disabling hearing loss in the world, with this figure expected to nearly double by 2050\. Deafness has a devastating effect on people, significantly affecting quality of life, education and employment prospects. The direct and indirect costs of hearing loss are estimated at £30B a year for the UK alone due to direct costs of life long treatment, personal costs to mental health, and lost economic productivity. There are no drugs for patients with hearing loss, the only treatments options available are medical devices such as hearing aids and cochlear implants. These devices only work for some patients and don't fully restore hearing for them. For patients with damage to the nerve cells of the ear (40m people globally), there are no treatments. Hearing devices do not work and these patients have no options. Patients and doctors have been demanding drugs that cure the underlying causes of all hearing loss conditions but particularly hearing caused by nerve damage, and this is the issue that Rinri Therapeutics was created to address. Rinri's approach is to repair the damage in the ear that causes hearing loss by replacing the damaged cells with ones that work. To do this, we are developing a unique cell-based therapy for patients with hearing loss caused by nerve damage. These cells will be injected near to the site of damage in the ear where they will grow. These new cells are then able to restore the broken connections in the inner ear. Once hearing is restored, the patient will be able to communicate properly and fully participate in society, engaging socially and economically without restriction. Currently, Rinri has shown that the therapy works and is safe in models of the disease and has shown that it can be made to high quality for patients. In this project, Rinri wants to complete its manufacturing development so it can produce clinical-grade cells, complete the background datasets, and develop the approach to deliver the product to patients. These project objectives will accelerate the pre-clinical development of Rincell-1 to demonstrate the safety, efficacy and manufacturability profile required by regulators for first in human clinical trials to demonstrate proof that the therapy works in humans and attract the funding required to take us through the remaining clinical program to the market.

The World Health Organisation reports deafness as the second leading cause of years lived with disability. Half a billion people in the world have disabling hearing loss resulting in enormous personal, social and economic hardship. The current standard of care for hearing loss are hearing devices, including hearing aids and cochlear implants. However, these devices do not address the underlying problem: damage to the inner ear. Currently, no treatments for hearing loss exist. Rinri Therapeutics is developing a new treatment, 'Rincell-1', a cell therapy with the potential to replace dead or damaged nerve cells in the inner ear and restore hearing. In order to conduct clinical trials, Rinri needs to develop measures of safety and effectiveness of this treatment. It is proposed that the first-in-human trials of Rincell-1 will be in combination with a cochlear implant (the current treatment for deaf people who no longer benefit from a hearing aid) as these implants have the capacity to remotely monitor inner ear health and, therefore, to assess the safety and effectiveness of a therapy in a clinical trial. Rinri have been working with global leaders in hearing research based at the University of Nottingham to develop the necessary measurement tools and surgical techniques to conduct a clinical trial of Rincell-1\. We request funds for the secondment of Dr. Faizah Mushtaq, an audiologist and clinically qualified scientist working at the University of Nottingham, to Rinri, in order to manage and accelerate the development and delivery of these tools and techniques. This secondment will prove directly beneficial to Faizah, Rinri, the University of Nottingham and the hearing loss scientific community. Specifically, Faizah will learn about the processes necessary to develop a clinical trial within an industry setting. Along with her existing clinical and research skills, this will provide her with an almost unique skillset in the hearing field that could be applied to the development of other novel hearing therapies in the future, which are desperately needed to address the global burden of hearing loss. Likewise, Rinri will gain from Faizah's extensive knowledge of monitoring hearing health in clinical and research settings, along with her unique understanding of hearing scientists and clinicians, the hearing device industry, and Rincell-1's target population: people with hearing loss. Ultimately, this secondment will enhance the exchange of ideas between Rinri and the University of Nottingham towards the development of a revolutionary new treatment for hearing loss.