Sensorion reported further analysis from its Proof of Concept (POC) Phase 2a clinical trial of SENS-401 for residual hearing preservation in adult patients following cochlear implantation. Analysis of the preliminary data will be presented at the Company’s KOL webinar taking place on July 5, 2023 (event details below). On June 19th, 2023, Sensorion announced that in preliminary data from the Phase 2a study, SENS-401 was detected in the perilymph of all 5 adult patients treated with the product.

Levels of SENS-401 were considered consistent with potential therapeutic effects after seven days of repeated oral treatment. The data unveiled shows that the study also assessed a number of secondary endpoints, including 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.

Further analysis suggests SENS-401 treated patients demonstrated the preservation of 21 dB of their residual hearing compared to the control group six weeks after cochlear implantation at 500 Hz. In the SENS-401-treated group (N=5), the loss of residual hearing was only 12 dB, contrasting with a larger loss of 33 dB observed in the control group of four participants not treated with SENS-401. This resulted in a difference of clinical significance of 21 dB between the two groups, suggesting SENS-401 provided a protective effect on early residual hearing loss after cochlear implantation.

These original and promising findings reinforce the hypothesis that SENS-401, by crossing the labyrinthine barrier to reach the cochlear compartment, has a positive effect on the preservation of residual hearing. The Phase 2a trial is a multicentric, randomized, controlled open-label 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.