Sensorion SA announces it has met the primary endpoint for its Proof of Concept (POC) Phase 2a clinical trial of SENS-401 for residual hearing preservation following cochlear implantation. The Phase 2a trial is a multicentric, randomized, controlled, open-label trial aimed at evaluating the presence of SENS-401 in the cochlea (perilymph) at therapeutic concentrations after 7 days of twice-daily oral administration prior to cochlear implantation due to moderately severe to profound hearing impairment (?primary endpoint?). Patients started treatment with SENS-401 seven days before implantation and continued to receive SENS-401 for a further forty-two days.

The study also assesses a number of secondary endpoints, including the change of hearing threshold from baseline to the end of the study in the implanted ear at several frequencies. The study has been developed in collaboration with Cochlear Limited (Cochlear), the global leader in implantable hearing devices. On February 1, 2024, Sensorion announced the completion of patient inclusion in the Phase 2a clinical trial of SENS-401 for the residual hearing preservation after cochlear implantation.

A total of 28 patients have been randomized and 25 patients have been implanted with a cochlear implant; 16 in the treated arm and 9 in the control non-treated arm. The presence of SENS-401 in the perilymph at a level compatible with potential therapeutic efficacy has been confirmed in 100% of the patients sampled, 7 days after the start of the treatment, confirming that the primary endpoint was met. These results confirm that SENS-401 administered orally crosses the labyrinth barrier.

The study is now completed, the follow-up of the last patients is still ongoing and the secondary endpoints including results on the preservation of the residual hearing will be available and analyzed later this year. The Company plans to publish the complete readout of the study in Third Quarter 2024.