(CercleFinance.com) – Sensorion announces the achievement of the primary endpoint in the phase 2a clinical study evaluating SENS-401 in the indication of preservation of residual hearing after cochlear implantation.
This Phase 2a study is a multicenter, randomized, controlled, open-label trial aimed at evaluating the presence
of SENS-401 in the cochlea (perilymph) at therapeutic levels after 7 days of twice-daily oral administration prior to cochlear implantation due to moderately severe to profound hearing loss.
The study was developed in collaboration with Cochlear Limited, the global leader in implantable hearing solutions.
The presence of SENS-401 in the perilymph was confirmed in 100% of patients sampled, 7 days after the start of treatment, at a level compatible with potential therapeutic efficacy, confirming that the main endpoint of the study was achieved. .
These results confirm that SENS-401, administered orally, crosses the labyrinthine barrier.
The Company plans to publish the full results of the study during the third half of 2024.
Nawal Ouzren, Managing Director of Sensorion, said: ‘We look forward to the publication of the full data set from this study, including secondary endpoints, which is expected to take place later this year. These positive results constitute a key step in the development plan for SENS-401, a promising drug candidate whose effectiveness we aim to demonstrate in protecting hearing loss in several strategic indications.
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