Sensorion Reports Positive Efficacy Data from SENS-401 Phase 2a Clinical Study
- Positive preliminary data showed SENS-401 has a clinically significant effect on the preservation of residual hearing after cochlear implantation in all adult patients treated so far
- On the 19th of June, Sensorion announced that the patients treated with SENS-401 showed presence of SENS-401 in perilymph. Analysis suggests preservation of 21 dB of their residual hearing compared to the control group six weeks after cochlear implantation at 500 Hz
- Data to be detailed at a webinar today Wednesday, July 5, 2023, led by Professor Yann Nguyen M.D., Ph.D and Sensorion's management team
MONTPELLIER, France, July 05, 2023--(BUSINESS WIRE)--Regulatory News:
Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today reports 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 today, Wednesday, 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 today 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.
Nawal Ouzren, Chief Executive Officer of Sensorion, stated: "We are very excited to see such promising new preliminary data for our ongoing Phase 2a clinical study of SENS-401. This is great news for our program and supports our confidence in the potential of our innovative therapy to prevent residual hearing loss in adult patients suffering from moderately severe to profound hearing disorders. This level of residual hearing preservation means patients have a better chance of understanding speech against background noise and perceiving more natural sound quality with speech and sounds."
Géraldine Honnet, M.D., Sensorion's Chief Medical Officer, added: "Two weeks ago we demonstrated that SENS-401 crossed the labyrinthine barrier to the cochlea. Today, following further analysis, we have gone much further and have shown SENS-401 potential to preserve early residual hearing six weeks after cochlear implantation. Patients treated with SENS-401 showed improved hearing preservation compared to the patients in the control group, corroborating the otoprotective potential of the molecule. We believe SENS-401 is a ground-breaking therapy with great potential in an area of significant unmet need and we are looking forward to seeing the final results of the study."
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