Phase 2a Trial for SENS-401 Completes Patient Enrollment for Cochlear Implant Hearing Preservation

Sensorion, a clinical-stage biotechnology firm dedicated to developing innovative treatments for hearing loss disorders, has completed the enrollment of patients for its Phase 2a clinical trial of SENS-401. This trial focuses on preserving residual hearing in adults after cochlear implant surgery. A total of 27 participants were enrolled in the trial, which is a multicenter, randomized, open-label study designed to assess the presence of SENS-401 in the cochlea after seven days of twice-daily oral intake. The treatment with SENS-401 is initiated seven days prior to the implantation and continues for an additional 42 days post-surgery.

The study has been conducted in collaboration with Cochlear Limited, a global leader in implantable hearing solutions. Géraldine Honnet, Sensorion's Chief Medical Officer, expressed her enthusiasm about the completion of the recruitment phase, which she views as a significant step in the development of SENS-401. Preliminary efficacy data from the trial have been promising, bolstering confidence in SENS-401's potential to prevent hearing loss.

SENS-401, also known as Arazasetron, is an orally administered small molecule that targets the protection and preservation of inner ear tissues from damage that leads to progressive hearing impairment. Sensorion is advancing SENS-401 through Phase 2a trials for the prevention of residual hearing loss in cochlear implant candidates and for the prevention of Cisplatin-Induced Ototoxicity. The drug has received Orphan Drug Designation from both the European Medicines Agency (EMA) for treating sudden sensorineural hearing loss and the U.S. Food and Drug Administration (FDA) for preventing ototoxicity in pediatric patients undergoing platinum-based chemotherapy.

Sensorion is a pioneering company in the field of hearing loss disorder therapies, addressing a significant unmet medical need globally. The company has established a unique R&D platform to deepen its understanding of inner ear diseases, allowing it to identify optimal drug targets and mechanisms. In addition to SENS-401, Sensorion is developing gene therapy programs for hereditary forms of deafness in partnership with the Institut Pasteur. These include SENS-501 (OTOF-GT) for deafness caused by otoferlin gene mutations and GJB2-GT for hearing loss related to GJB2 gene mutations. Sensorion is also engaged in biomarker identification to enhance the diagnosis of these conditions. The company's clinical-stage portfolio includes SENS-401 in Phase 2 trials for Cisplatin-Induced Ototoxicity prevention and residual hearing loss prevention in cochlear implant patients, as well as a completed Phase 2 study in Sudden Sensorineural Hearing Loss.