Sensorion announced the publication of new positive data from its SENS-401 Phase 2a clinical trial in the preservation of residual hearing in adult patients following cochlear implantation. New medical data and analysis of results from the SENS-401 Phase 2a clinical trial after cochlear implantation were presented at the 17th International Conference on Cochlear Implants and Other Implantable Technologies (CI2024) on July 13, 2024, in Vancouver, Canada, by study investigator, Professor Stephen O'Leary, M.D., Ph.D. The study design included a number of secondary endpoints, notably the change of hearing threshold from baseline to the end of the treatment period in the implanted ear at several frequencies. Study entry criteria required patients to have a pure tone audiometry (PTA) threshold of 80 dB or better (i.e., =80 dB) at 500 Hz, defined as indicating a minimal level of residual hearing.

The results show that the administration of SENS-401 reduced hearing loss following cochlear implantation. Six weeks post cochlear implantation (corresponding to end of SENS-401 treatment), the data indicate that the mean hearing loss induced by the surgery at 500 Hz is 19 dB for patients treated with SENS-401 (N=16) compared to 32 dB for control group of SENS-401 untreated patients (N=8). Similar clinically meaningful difference is observed for the mean of the three following frequencies (250, 500 and 750 Hz) with 16 dB in the SENS-401 treated group compared to 31 dB in the control group.

These good results remained clinically meaningful over time and up to the last study visit fourteen weeks after cochlear implantation and confirm the key role of SENS-401 in preserving residual hearing. On March 11, 2024, Sensorion announced that it had successfully met the primary endpoint of the SENS-401 clinical trial for the preservation of residual hearing in adult patients following cochlear implantation. The presence of SENS-401 in the perilymph at a level compatible with potential therapeutic efficacy has been confirmed in 100% of the patients sampled, seven days after the start of the treatment, confirming that the primary endpoint was met.

These results confirm that SENS-401 administered orally crosses the labyrinth barrier. The study is developed in collaboration with Cochlear Limited, the global leader in implantable hearing solutions. The Company plans on communicating the full final data later in third quarter of year 2024.