Sensorion announced that the initiation of a Proof of Concept (POC) clinical trial of SENS-401 (Arazasetron) in patients scheduled for cochlear implantation has been approved by regulatory authorities in France. Approval has been granted to launch a Phase 2a trial with SENS-401 for hearing preservation in patients who, due to having moderately severe to profound hearing impairment, are scheduled for cochlear implantation. The trial will be a multicenter, randomized, controlled, open-label trial to evaluate the presence of SENS-401 in the cochlea (perilymph) after 7 days of twice-daily oral administration in adult participants prior to cochlear implantation.
Patients will receive SENS-401 for 49 days. The trial will also assess a number of secondary outcome measures, including the change of hearing threshold from baseline to the end of the study in the implanted ear at several frequencies. As previously announced, first patient enrolment is anticipated by mid-2022.
At the beginning of 2021, Sensorion released positive preclinical data demonstrating that the combination of its SENS-401 molecule alongside a cochlear implant helped reduce loss of residual hearing at a frequency located beyond the electrode array. Preservation of natural' hearing is particularly important in speech recognition. Preclinical studies were undertaken in collaboration with the global leader in implantable hearing, Cochlear Ltd.