Sensorion Announces the Completion of Patient Inclusion in Phase 2a Clinical Trial of SENS-401 for Residual Hearing Preservation After Cochlear Implantation

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 the recruitment of the last patient in its Phase 2a clinical trial of SENS-401 for residual hearing preservation in adult patients following cochlear implantation.

A total of 33 patients have been screened to enroll at least 27 patients in the multicentric, randomized, controlled open-label Phase 2a trial aimed at evaluating the presence of SENS-401 in the cochlea (perilymph) after 7 days of twice-daily oral administration in adult patients 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 has been developed with Sensorion’s partner, Cochlear Limited, the global leader in implantable hearing devices.

Géraldine Honnet, M.D., Chief Medical Officer of Sensorion, said: "We are delighted to announce the completion of recruitment in the Phase 2a clinical trial of SENS-401 for the residual hearing preservation, a key milestone in a study which is instrumental in the development plan of SENS-401. I would like to thank the patients and physicians involved in the study for their trust and commitment. The first preliminary efficacy data from this clinical trial were very promising and reinforce our confidence in the potential of SENS-401 in hearing loss prevention."

The first SENS-401 results published in July 2023 by Sensorion indicated positive efficacy and safety preliminary data showing that SENS-401 has a clinically significant effect on the preservation of residual hearing after cochlear implantation in all adult patients treated to date. Sensorion plans to publish the primary endpoint data readout in H1 2024.

About SENS-401

SENS-401 (Arazasetron), Sensorion’s clinical stage lead drug candidate, is an orally available small molecule that aims to protect and preserve inner ear tissue from damage responsible of progressive or sequelae hearing impairment. Sensorion currently develops SENS-401 in a Phase 2a for the prevention of residual hearing loss in patients scheduled for cochlear implantation. In addition, Sensorion assesses SENS-401 in a Phase 2 clinical trial for the prevention of Cisplatin Induced Ototoxicity. SENS-401 has been granted Orphan Drug Designation by the EMA in Europe for the treatment of sudden sensorineural hearing loss, and by the FDA in the U.S. for the prevention of platinum-induced ototoxicity in pediatric population.