Auris Medical gives up on AM-111 trial in sudden deafness

29 November 2017

Shares of Swiss biotech firm Auris Medical Holding (Nasdaq: EARS) plunged 48.65% to $0.42 yesterday, after the clinical-stage company focussed on otolaryngology announced disappointing top-line results from the HEALOS Phase III clinical trial of AM-111 in severe to profound sudden deafness.

Overall, the HEALOS trial did not meet the primary efficacy endpoint of a statistically-significant improvement in hearing from baseline to Day 28 compared to placebo for either active treatment groups. However, a post-hoc analysis of the subpopulation with profound acute hearing loss revealed a clinically- and statistically-significant improvement in the AM-111 0.4mg/mL treatment group, Auris pointed out.

Based on the findings from the HEALOS trial, Auris Medical has concluded that the very similar design of the currently ongoing ASSENT trial is no longer adequate for testing AM-111. Therefore the ASSENT trial will be terminated early.

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