Sensorion Reports Positive Secondary Efficacy Data from SENS-401 Phase 2a Trial for Residual Hearing Loss Preservation

Sensorion, a leading clinical-stage biotech firm, has unveiled promising new data from its SENS-401 Phase 2a clinical trial aimed at preserving residual hearing in adults post-cochlear implantation. The announcement was made at the 17th International Conference on Cochlear Implants and Other Implantable Technologies (CI2024) in Vancouver, Canada, by Professor Stephen O'Leary, M.D., Ph.D.

The clinical trial design featured several secondary endpoints, primarily focusing on the change in hearing threshold from baseline to the end of the treatment period in the implanted ear at various frequencies. Participants were required to have a pure tone audiometry (PTA) threshold of 80 dB or lower at 500 Hz, indicating a minimal level of residual hearing. The trial demonstrated that SENS-401 reduced hearing loss following cochlear implantation. Six weeks after implantation, data showed that the mean hearing loss at 500 Hz was 19 dB for patients treated with SENS-401 compared to 32 dB in the control group of untreated patients. This significant difference was also observed at frequencies of 250, 500, and 750 Hz, where the treated group showed a mean hearing loss of 16 dB compared to 31 dB in the control group. These beneficial results remained consistent up to fourteen weeks post-implantation.

On March 11, 2024, Sensorion announced the successful attainment of the primary endpoint of their SENS-401 clinical trial. The presence of SENS-401 in the perilymph at levels compatible with potential therapeutic efficacy was confirmed in all patients sampled seven days after treatment commenced. This finding reinforces that the orally administered SENS-401 can cross the labyrinth barrier, highlighting its potential therapeutic benefits. The study was conducted in partnership with Cochlear Limited, a global leader in implantable hearing solutions.

Sensorion’s Chief Executive Officer, Nawal Ouzren, expressed enthusiasm over the findings, stating, "These new positive findings from our Phase 2a clinical trial on SENS-401 demonstrate its clinically meaningful effect in preserving the residual hearing of patients undergoing cochlear implantation. Achieving this key secondary endpoint supports our goal to enhance the hearing quality of patients undergoing such surgeries. We plan to release the full final data later in Q3 2024, as we continue to focus on developing innovative hearing care therapies to address significant global needs."

Additionally, Sensorion’s Chief Medical Officer, Géraldine Honnet, M.D., emphasized the drug's efficacy in preserving residual hearing. Dr. Honnet highlighted the difference in hearing loss between the treated and control groups, noting that the effect persisted up to 14 weeks post-implantation, with the treated group experiencing a loss of 25 dB at 500 Hz compared to 35 dB in the control group. She extended gratitude to all patients, partners, and investigators involved in the study.

The full final data is anticipated for release later in Q3 2024.

SENS-401, also known as Arazasetron, is an orally available small molecule designed to protect and preserve inner ear tissue from damage that could lead to progressive or residual hearing impairment. Sensorion is currently developing SENS-401 for the prevention of residual hearing loss in patients undergoing cochlear implantation and in a Phase 2 trial for preventing Cisplatin-Induced Ototoxicity. The European Medicines Agency (EMA) has granted SENS-401 Orphan Drug Designation for treating sudden sensorineural hearing loss, and the U.S. Food and Drug Administration (FDA) has granted the same designation for preventing platinum-induced ototoxicity in pediatric patients.

Sensorion focuses on pioneering novel therapies to restore, treat, and prevent hearing loss disorders. The company has developed a unique R&D platform to better understand inner ear diseases, selecting optimal targets and mechanisms of action for potential drug candidates. Sensorion's portfolio includes gene therapy programs aimed at hereditary monogenic forms of deafness and clinical-stage small molecule programs for treating and preventing hearing loss disorders. In collaboration with the Institut Pasteur, Sensorion is developing SENS-501 (OTOF-GT) and GJB2-GT to address hearing loss caused by specific genetic mutations. The company is also working on identifying biomarkers to improve diagnosis and treatment of these conditions.