Sensorion SA reports results from the 115-patient Phase 2 AUDIBLE-S study of SENS-401 (Arazasetron), for the treatment of sudden sensorineural hearing loss (‘SSNHL'). SENS-401 was safe and well tolerated, however, it did not meet the primary endpoint of 15 dB, a significant improvement in pure tone audiometry (PTA, dB) in the affected ear from baseline in comparison to placebo at the end of the four-week treatment period. A sub-analysis in participants with hearing threshold > 80dB, representing those with severe hearing loss, showed a better response compared to placebo at the two doses.

This subgroup accounted for 30% of the overall study population. These results confirm the data obtained in preclinical model of severe noise induced hearing loss. Sensorion will continue to evaluate the data from the AUDIBLE-S study and the secondary endpoints results will be released mid-March.

It will outline plans for the development of SENS-401 SSNHL at that point.