Sensorion announced that the first patient has been enrolled in its proof-of-concept clinical trial of SENS-401 (Arazasetron) in patients scheduled for cochlear implantation. At the beginning of 2021, Sensorion disclosed positive preclinical data demonstrating that the combination of SENS-401 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. The Phase 2a trial is a multicenter, randomized, controlled, open-label trial aimed at evaluating the presence of SENS-401 in the cochlea (perilymph) after 7 days of twice-daily oral administration in adult participants prior to cochlear implantation due to moderately severe to profound hearing impairment. Eligible participants in France and Australia will be randomized on Day 1 to either Arm A or Arm B in ratio 2:1 (with the aim of enrolling 27 participants in total: 18 participants in Arm A and 9 participants in Arm B). Arm A participants will commence dosing with twice-daily oral 43.5 mg SENS-401 for 7 days prior to their scheduled cochlear implant surgery on Day 8 and will continue SENS-401 up to 42 days from day of surgery inclusive.

Arm B participants will not receive any treatment other than their scheduled cochlear implant surgery. The trial will also assess several secondary outcome measures, including the change of hearing threshold from baseline to the end of the study in the implanted ear at several frequencies.