MONTPELLIER, FRANCE — French biotech firm Sensorion announced the publication online, ahead of print, of data in the Otology & Neurology journal, showing the otoprotective potential of twice-daily oral SENS-401 in preclinical models.
The company evaluated the efficacy of SENS-401 against severe acoustic trauma-induced hearing loss in a male rat model using auditory brainstem response (ABR), distortion product otoacoustic emissions (DPOAE) and histology.
Results showed that twice daily, lower doses of SENS-401 for 28 days was the optimal dosing regimen for hearing protection using all outcome measures.
Further experiments demonstrated that this treatment regimen was able to deliver clinically relevant and statistically significant otoprotection and hearing recovery when the administration was delayed by as much as 96 hours after acoustic trauma (the latest treatment initiation time-point tested).
A responder analysis showed that oral SENS-401 treatment not only strongly increased the percentage of subjects with clinically significant hearing recovery compared to placebo, but also enhanced the degree of individual hearing recovery observed.
According to the company, these data on otoprotection and hearing recovery supports SENS-401 as a promising clinical candidate for acute onset sensorineural hearing loss, including when treatment is not initiated immediately.
“These results provide support for the translational development of SENS-401 in sudden sensorineural hearing loss (SSNHL) and publication in the respected Otology & Neurology journal also provides additional important peer-validation. SENS-401 offers the potential to make a real difference to patients’ lives as a potential first-in-class treatment, and we look forward to starting the Phase 2 of SENS-401 in SSNHL for which we received the authorization in Europe and Canada.”
–Nawal Ouzren, Sensorion CEO