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- Safe and well tolerated in 115-patient SSNHL study; primary endpoint not met
- Sensorion will continue to analyze the data from the AUDIBLE-S study and update the market mid-March following the analysis of the secondary endpoints
- Sensorion continues to develop SENS-401 in other indications
- Three preclinical gene therapy programs, aimed at correcting hereditary monogenic forms of deafness, are in progress
Regulatory News:
Sensorion (PARIS:ALSEN) (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 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 we obtained in our 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. We will outline plans for the development of SENS-401 SSNHL at that point.
“We are encouraged by the SENS-401 activity data that showed a continuous improvement from day 7 until day 28. We will review the full data as soon as possible and explore in particular the PTA comparisons at day 84 and the other secondary endpoints in the trial to determine the best development path for SENS-401,” commented Géraldine Honnet, CMO of Sensorion.
“We’re naturally disappointed that the Phase 2 AUDIBLE-S trial of SENS-401 did not meet the primary endpoint of the study. However, we are looking forward to reviewing the secondary endpoints once these become available by mid-March. Sensorion is committed to continuing to develop novel therapies in indications to restore, treat and prevent hearing loss disorders. Through our pioneering R&D technology platform and with a number of promising new therapeutic approaches, including …
Full story available on Benzinga.com
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