The company’s lead therapeutic candidate, Rincell-1, receives innovative medicine designation under new programme designed to accelerate the drug approval process and improve patient access in the United Kingdom.
Rinri appoints Professor Doug Hartley as Chief Medical Officer, and Sheila Casserly as Director of Clinical Operations, to lead the company’s clinical development strategy to support the continued advancement of Rincell-1 towards first-in-human trials.
SHEFFIELD, UK, 3rd May, 2022: Rinri Therapeutics, a biotechnology company developing proprietary regenerative cell therapies for sensorineural (SNHL) hearing loss, has been awarded an Innovation Passport under the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) Innovative Licensing and Access Pathway (ILAP), to pursue accelerated clinical development and patient access for Rincell-1, the company’s lead candidate. The company has also made two senior appointments to build its clinical capabilities in advance of clinical trials.
Rincell-1 is a first-in-class regenerative cell therapy that seeks to reverse auditory neuropathy, a form of SNHL specifically affecting the transmission of nerve signals from the inner ear to the auditory centres of the brain. Rincell-1 has demonstrated long-term safety and efficacy in pre-clinical models, indicating potential levels of functional restoration of hearing that would be clinically significant in humans.
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.”
To lead the advancement of Rincell-1 towards first-in-human trials, expected in 2024, Rinri has appointed Douglas Hartley, an internationally recognised and award-winning Professor of Otology and consultant ENT surgeon, as Chief Medical Officer. His clinical and academic work, which spans over two decades, is dedicated to the provision of high-quality care, and improving clinical outcomes for individuals with hearing loss.
Sheila Casserly also joins the team as Director of Clinical Operations, bringing a wealth of global experience in clinical trial operations leadership, having previously held positions within biotech, pharma and CRO organisations. Most recently, Sheila was 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.”
Despite being the most common form of hearing loss globally, there is currently no approved pharmacological treatment available for SNHL. Rincell-1 targets auditory neuron degeneration. Rinri’s technology has the potential to address huge unmet need and help ease the UK’s socio-economic and healthcare burdens. Untreated hearing loss costs the UK economy £25.5bn a year.
To receive an Innovation Passport, Rincell-1 met the following criteria: (1) the condition is seriously debilitating; (2) the program for a special population; and (3) the medicine has the potential to offer transformative benefits to patient outcomes. The decision to award the Innovation Passport to Rinri’s Rincell-1 candidate was made by the ILAP Steering Group, which is comprised of representatives from MHRA, NICE, and the Scottish Medicines Consortium.