Auris' Outlook Bleak In Tinnitus After Failure Of Initial Phase III Trial
The Swiss biotech still holds out hope that its NMDA antagonist Keyzilen will hit its primary endpoint in a European Phase III study in acute tinnitus, but a largely US-based first Phase III trial missed both co-primary endpoints.
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Auris Medical Holding's investigational tinnitus product, Keyzilen, has failed to meet its primary efficacy endpoint in an interim analysis of a second Phase III trial, adding to a series of clinical disappointments over the past few years for the Swiss biotech.
A clinical trial failure at Auris and a revoked patent at Johnson & Johnson that will lead to the emergence of real US biosimilar competition passed virtually unnoticed last week. It's that time of year again.
Auris Medical Holding AG has moved its hearing loss therapeutic, AM-111, into a second Phase III study, making it the most advanced drug in the pipeline for the treatment of sudden deafness, according to Biomedtracker.