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Auris Medical's Tinnitus Candidate Keyzilen Fails Second Phase III Trial

06:08 EDT 14 Mar 2018 | Genetic Engineering News

Auris Medical has acknowledged the second Phase III failure in 19 months for its tinnitus candidate Keyzilen ® (AM-101), promising a future update on its plans for the company’s co-lead development program. Auris said Keyzilen failed the TACTT3 trial ( NCT02040194 ) by missing its primary efficacy endpoint of a statistically significant improvement in the Tinnitus Functional Score from baseline to day 84 in participants treated with the drug compared to those treated with placebo, either in the overall population or in the otitis media subpopulation. TACTT3, which was conducted in Europe, was designed to assess Keyzilen in acute and postacute inner ear tinnitus following traumatic cochlear injury or otitis media. The trial enrolled a combined 893 participants in the acute tinnitus stage (Stratum A) and the postacute tinnitus stage (Stratum B). The trial’s status was updated to “completed” as of January 16, the date of ...

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