Auris Medical Holding AG's AM-111 to treat severe to profound sudden deafness did not meet its main goal of significantly improving hearing in a phase 3 trial.
The Healos trial, which was evaluating the safety and efficacy of AM-111, did not meet the primary endpoint of statistically significant improvement in hearing compared to a placebo at day 28.
A post-hoc analysis of the subpopulation with profound acute hearing loss showed a clinically and statistically significant improvement in the AM-111 0.4 mg/mL treatment group.
In addition, the drug was well tolerated and the primary safety endpoint was met.
Auris Medical also decided to terminate a second ongoing clinical trial called Assent, which had a design very similar to the Healos trial. The company said the design of the Assent trial was no longer adequate to test AM-111.
