Rinri Therapeutic announced the approval of its clinical trial application by UK drug regulator MHRA, greenlighting the first-in-human trial for the company’s lead regenerative cell therapy, Rincell-1.
Clinical proof-of-concept data from the phase 1/2a trial of Rincell-1, a first-in-class optic neural progenitor cell therapy, is expected within 12 months of trial initiation.
Taking place at three leading research centers in the UK, the randomized open-label trial will involve 20 patients undergoing cochlear implantation for hearing loss, 10 with postsynaptic auditory neuropathy spectrum disorder and 10 with severe-to-profound age-related hearing loss. Within each group, patients will be randomly assigned to receive a single dose of Rincell-1 in addition to cochlear implantation or cochlear implantation alone.
While current standard-of-care treatments like cochlear implants help manage the symptoms of sensorineural hearing loss, their effectiveness depends on the integrity of the cochlear nerve. Rincell-1 is an auditory neuron progenitor cell line that can differentiate into mature auditory neuron cells, delivered to the cochlea, replacing damaged sensory cells in the inner ear to restore hearing.
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