Auris Medical reports second late-stage study failure for tinnitus therapy Keyzilen

Auris Medical said that preliminary top-line results suggest that the Phase III TACTT3 study of Keyzilen, also known as AM-101, in the treatment of acute inner ear tinnitus failed to meet its primary efficacy endpoint. Shares in the company fell as much as 30 percent on the news.

The trial's main goal was improvement in the Tinnitus Functional Score from baseline to day 84 in the active treated group compared to placebo either in the overall population or in the otitis media subpopulation. Auris noted that it is investigating the outcomes of the TACTT3 trial, as well as those in the previously conducted sister trial TACTT2, and will provide an update in due course.

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The company reported in 2016 that the TACTT2 study of Keyzilen in acute inner ear tinnitus failed to meet its two co-primary efficacy endpoints of significant changes in tinnitus loudness and tinnitus burden on day 84 compared to placebo. Following the TACTT2 results, Auris decided to amend the TACTT3 trial, with the change in Tinnitus Functional Index score elevated from a key secondary endpoint to an alternate primary efficacy goal.

Meanwhile, in November last year, Auris announced a halt to the Phase III ASSENT study of AM-111 in patients with sudden deafness after the similar late-stage HEALOS trial failed to meet its primary endpoint.

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