Sensorion sinks as SENS-401 Phase II trial misses in hearing loss
French hearing loss specialist Sensorion (Euronext: ALSEN) saw its share plummet 42% yesterday, when it announced disappointing research results, and a further 13.7% to 0.91 euros today.
Sensorion presented results from the 115-patient Phase II AUDIBLE-S study of SENS-401 (Arazasetron), for the treatment of sudden sensorineural hearing loss (SSNHL), showing the candidate was safe and well tolerated, but 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 we obtained in our preclinical model of severe noise induced hearing loss.
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