Therapy Areas: Devices
Sensorion achieves primary endpoint in SENS-401 Phase 2a clinical study for cochlear implant residual hearing preservation
11 March 2024 -

Sensorion ( Paris: ALSEN), a biotechnology firm focused on hearing loss disorders, announced on Monday that it has successfully met the primary endpoint for its Phase 2a clinical trial of its lead drug candidate SENS-401. The study, conducted in collaboration with Cochlear Limited (COH), confirms the presence of SENS-401 in the perilymph of cochlear implant patients, demonstrating therapeutic efficacy potential. The trial included 28 patients and revealed positive outcomes, with the complete study readout scheduled for Q3 2024.

On 1 February 2024, Sensorion announced the completion of patient inclusion in the Phase 2a trial, with 25 patients implanted. SENS-401 demonstrated presence in perilymph at therapeutic concentrations in all patients sampled seven days after treatment initiation, meeting the primary endpoint. The ongoing follow-up will provide additional insights and secondary endpoints will be analyzed later this year.

In 2017, Sensorion and Cochlear initiated a research collaboration on SENS-401. Upon the study's complete readout, Cochlear has the option to negotiate global distribution rights for SENS-401 related to certain implantable devices.

SENS-401 is an orally administered small molecule designed to preserve inner ear tissue. The Phase 2a trial focused on preventing residual hearing loss in cochlear implant patients, while another Phase 2 trial addresses Cisplatin-Induced Ototoxicity. SENS-401 has Orphan Drug Designation in Europe for sudden sensorineural hearing loss and in the US for platinum-induced ototoxicity in paediatric patients.

Sensorion's extensive R&D platform targets the pathophysiology of inner ear diseases, with gene therapy programs addressing hereditary deafness. SENS-501 (OTOF-GT) and GJB2-GT, developed in collaboration with the Institut Pasteur, aim to correct gene mutations leading to deafness. The company is also working on biomarkers for improved diagnosis of hearing disorders. Sensorion's clinical-stage portfolio includes SENS-401 and ongoing collaborations with Cochlear Limited.