Biotechnology company Rinri Therapeutics has been awarded an Innovation Passport by the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) for its cell therapy targeting a form of hearing loss.
The Innovation Passport, which is awarded through the MHRA’s Innovative Licensing and Access Pathway (ILAP), will enable Rinri Therapeutics to purse accelerated clinical development and patient access for its lead candidate – Rincell-1.
Rincell-1 is a first-in-class regenerative cell therapy that seeks to reverse auditory Neuropathy, a form of sensorineural (SNHL) hearing loss specifically affecting the transmission of nerve signals from the inner ear to the auditory centres of the brain.
The therapy has shown safety and efficacy in pre-clinical models, indicating potential levels of functional restoration of hearing that would be clinically significant in humans.
There are currently no approved treatments for SNHL, despite it being the most common form of hearing loss globally.
Dr Simon Chandler, CEO, Rinri Therapeutics, said: “We are delighted to have been awarded the Innovation Passport by the MHRA, which is the entry point to the ILAP. This is an important step in Rinri’s efforts to bring an effective pharmacological treatment as rapidly as possible to SNHL patients.”
The company has also made two senior appointments to build its clinical capabilities in advance of clinical trials.
Rinri Therapeutics has hired Douglas Hartley as Chief Medical Officer to help lead the advancement of Rincell-1. The company has also hired Sheila Casserly as Director of Clinical Operations. Casserly was most recently the Project Director for the UK’s Covid-19 Human Challenge Study, supporting the development of new vaccines and treatments for Covid-19.
Dr Chandler added: “Doug and Sheila’s decades of experience bring the proven clinical leadership into Rinri required to successfully guide and deliver our clinical strategy. We look forward to continued collaboration with regulators, health technology assessment bodies and other partners as we advance Rincell-1 through clinical development and bring hope to the hearing loss community that a new, ground-breaking treatment might soon be available.”