Sensorion Announces it Has Met Primary Endpoint for SENS-401 Phase 2a Clinical Study for Residual Hearing Preservation

Regulatory News:

Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, today 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 Q3 2024.

Nawal Ouzren, Chief Executive Officer of Sensorion, said: "We are delighted to announce we met the primary endpoint for the Phase 2a clinical trial of SENS-401 for residual hearing preservation. We are looking forward to the publication of the full dataset of this study, including secondary endpoints, that is expected later this year. We would like to thank the patients and physicians involved in the study, as well as our industrial partner Cochlear Limited, with whom we designed this study, for their confidence and commitment. Those positive results are a key milestone in our development plan for SENS-401, a promising drug-candidate, for which we have the ambition to demonstrate the efficacy in hearing loss protection in several strategic indications."