Sensorion, which specializes in the development of novel therapies to restore, treat, and prevent within the field of hearing loss, has reported further analysis of the phase 2a SENS-401 Proof of Concept (POC) clinical trial for preservation of residual hearing in adult patients after implantation. cochlea.
On June 19, Sensorion announced that in preliminary data from a phase 2a study, SENS-401 was detected in the perilymph of all five adult patients treated with the product. The SENS-401 level was thought to be consistent with a potential therapeutic effect after seven days of repeated oral treatment.
Sensory study details
New data suggest that the study also assessed secondary endpoints, including changes in hearing threshold from baseline to end of treatment in the implanted ear at multiple frequencies. Study entry criteria required patients to have a pure tone audiometry (PTA) threshold of 80 dB or better (ie, ≤80 dB) at 500 Hz, which is defined as an indication of a minimal degree of residual hearing.
Further analysis showed that patients treated with SENS-401 exhibited 21 dB of preservation of their residual hearing compared to the control group six weeks after cochlear implantation at 500 Hz.
In the group treated with SENS-401, residual hearing loss was only 12 dB, in contrast to the greater loss of 33 dB observed in the control group of four participants not treated with SENS-401. This resulted in a difference of 21 dB of clinical significance between the two groups, suggesting SENS-401 exerts a protective effect on early residual hearing loss after cochlear implantation. This original and promising finding reinforces the hypothesis that SENS-401, by crossing the maze barrier to reach the cochlear compartment, has a positive effect on the maintenance of residual hearing.
The phase 2a trial was a multicentric, randomized, controlled, open label trial aimed at evaluating the presence of SENS-401 in the cochlea (perilymph) after seven days of twice-daily oral administration in adult patients before cochlear implantation because it is moderately severe. to severe hearing loss. The patient started treatment with SENS-401 seven days before implantation and continued to receive SENS-401 for another 42 days.
Natural sound quality
Nawal Ouzren, chief executive of Sensorion, said: “We are very pleased to see promising new preliminary data for our ongoing phase 2a clinical study of SENS-401. This is great news for our program and supports our belief in the potential of our innovative therapy to prevent residual hearing loss in adult patients with moderate to severe hearing loss. This level of residual hearing preservation means patients have a better chance of understanding speech against background noise and experiencing a more natural sound quality with both speech and voice.”
Géraldine Honnet, Sensorion’s chief medical officer, said: “Two weeks ago, we demonstrated that SENS-401 crosses the labyrinth barrier to the cochlea. Today, after further analysis, we have gone a step further and have demonstrated the potential for SENS-401 to maintain residual hearing as early as six weeks after cochlear implantation. Patients treated with SENS-401 showed increased hearing preservation compared with patients in the control group, amplifying the molecule’s autoprotective potential. We believe SENS-401 is a breakthrough therapy with great potential in an area of significant unmet need and we look forward to seeing the final results of this study.”
Earlier this year, the company announced a collaboration with EVEON on an injectable system to provide gene therapy inner ear treatment.