Auris Medical is amending the protocol of its ongoing Phase III trial of Keyzilen in acute inner ear tinnitus, based on data from a separate, recently completed Phase III trial that failed to meet its two co-primary endpoints.
In the amended protocol, the change in Tinnitus Functional Index score will be elevated from a key secondary endpoint to an alternate primary efficacy endpoint. Certain patient subgroups will be included in confirmatory statistical testing, and the trial size will be increased, Auris said.
So far, the trial has enrolled more than 300 patients during the acute tinnitus stage and approximately 330 patients in the post-acute stage, and the company expects enrollment to resume in early 2017, with top-line results in early 2018. Auris plans to discuss both trials with the FDA in December.
While the previous trial failed to meet its primary endpoints, data did show favorable treatment effects on TFI in a pre-specified subgroup of patients suffering from tinnitus following a middle ear infection. The trial had also enrolled patients with tinnitus following traumatic cochlear injury.