Overview
Rinri Therapeutics was founded in 2018 to develop first-in-class regenerative cell therapies for individuals living with hearing loss.
Founded from cutting edge science, based on the pioneering work of Professor Marcelo Rivolta – a recognised world leader in the field of sensory stem cell biology – this is a world class team supported by proven cell therapy expertise, backed by leading investors.
Rinri is the world’s leading company to be exploring the potential of a regenerative cell therapy for sensorineural hearing loss, and the only company to be addressing neuro hearing loss.
Rinri’s initial focus is auditory nerve-related hearing loss, before further developing the technology to restore hearing in all sensorineural hearing loss patients.
Discovery
For our cell therapy approach to work, there is a need for a reliable, renewable source of human progenitors, with the ability for sensory replacement.
It has been possible to derive auditory sensory cells from pluripotent stem cells for some time. However, earlier generations of these cells achieved different degrees of functional maturation, and none demonstrated the capability to restore function. The reason was our impaired understanding of the molecular events involved in normal human auditory development. With this understanding, the Rivolta lab developed the first functionally restorative human auditory sensory cells, through the application of a developmentally informed manufacturing protocol. Under specific laboratory conditions, the Rivolta lab showed that their progenitor cells were able to mature into functional auditory neurons. These cells exhibit the same morphology and electrophysiology as native cells of the inner ear, as well as having the same profile of molecular characteristics.
From Laboratory to Patients
Preclinical studies clearly demonstrated that when progenitors of auditory neurons were delivered to the cochlea they survived, engrafted, matured and re-established neural connections to the auditory hair cells and the wider auditory neural architecture. In models of auditory neuropathy these cells resulted in a reversal of hearing loss and ~40% improvement in the hearing threshold. To find out on this work, please read here.
Following this ground-breaking proof of concept data, significant progress has been made to refine and optimise the manufacturing technology improving yield, efficiency, potency and purity to the levels required to start the pioneering journey towards first in man clinical trials and to ultimately realise the potential of cell therapy for hearing loss.
Journey to the Centre of the Cochlea
Whilst Rinri’s cells can repair the auditory nerve, a key limitation in hearing loss therapeutics has been gaining access to the cochlea, which is buried deep in the skull, encased by the hardest bone in the human body.
Translation into humans has, until now, been hampered by limited anatomical knowledge and the lack of a safe access to the site of administration within the central core of the cochlea.
Using a detailed representation of the microanatomy of the peripheral auditory neural structure, Rinri with a team of surgeons and scientists from the UK, Sweden and Canada have been able to validate a safe, secure surgical access route to the central core of the human cochlea.
To find out more on this work, please read “Unlocking the human inner ear for therapeutic intervention” published in Scientific Reports here.
Clinical Trials
Clinical Development
In the case of hearing loss, it is difficult to assess the impact of a new therapy since the inner ear is very difficult to access. However, the electrode array of a cochlear implant, which is threaded through the cochlea during cochlear implant surgery can double up as an excellent objective measurement tool. Rinri have led a series of studies in which equipment used by clinicians to assess measures of cochlear health and performance has been repurposed and used for longitudinal post-surgical self-assessment. This a fantastic way of evaluating what normal cochlear health looks like in cochlear implant users, generating data that Rinri can compare against when assessing the safety and efficacy of our cell therapy treatments.
First in Human Trials
Rinri is currently preparing regulatory submissions for the first in human clinical trials of Rincell-1, which are due to commence in the near future. Rinri’s cells will be administered to adults with severe-to-profound auditory nerve-related hearing loss who are eligible under UK NICE guidance (TA566) to receive a cochlear implant.
Further details will be uploaded to our website and social media accounts but for more information, please contact clinicaltrials@rinri-therapeutics.com
To find out more on this, please read “Self-assessment of cochlear health by cochlear implant recipients” published in Frontiers in Neurology here