Sensorion Reports Promising Preliminary Data from SENS-401 Phase 2a Clinical Study

Regulatory News:

Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announces promising preliminary results from its Proof of Concept (POC) Phase 2a clinical trial of SENS-401 for residual hearing preservation following cochlear implantation. Sensorion will communicate further analysis of SENS-401 study during the KOL webinar it will host on July 5, 2023.

The Phase 2a trial is a multicentric, 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. Patients start treatment with SENS-401 7 days before implantation and continue to receive SENS-401 for a further 42 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.

Preliminary results

In 5 out of 5 patients, the presence of SENS-401 in the perilymph at a level compatible with therapeutic efficacy has been confirmed, 7 days after the start of the study. These results confirm that SENS-401 crosses the labyrinth barrier and may have an effect on the preservation of the residual hearing.

Géraldine Honnet, M.D., Sensorion’s Chief Medical Officer, declared: “Presence of SENS-401 in the cochlea in 100% of patients having undergone cochlear implantation surgery confirms our confidence in the potential of our small molecule. These preliminary results support Sensorion’s ambition to provide solutions for people with hearing loss disorders. We will report further data from our Phase 2a study of SENS-401 in association with cochlear implants during our KOL webinar to be held on July 5, 2023.”

Professor Yann Nguyen, M.D., Ph.D., ENT Surgeon at the Otolaryngology Department at the Hospital Pitié Salpêtrière, Paris, France, said: “The SENS-401 preliminary data suggests a compelling clinical profile for patients scheduled for cochlear implantation. These results are very promising, and I look forward to seeing further data of SENS-401, which has the potential to produce clinical benefits to patients suffering from hearing loss.”