New failure for Auris in tinnitus trial
The future of Keyzilen, an in-ear injection being developed by Auris Medical (Nasdaq: EARS) in acute inner ear tinnitus, looks uncertain after another trial failure.
In August 2016 it was announced that the drug had failed to meet the co-primary efficacy endpoints in the TACTT2 trial of statistically-significant changes in tinnitus loudness and tinnitus burden, compared to placebo, and then this week a further failure was announced.
Preliminary top-line data from the TACTT3 trial indicate that this study did not meet its primary efficacy endpoint of a statistically-significant 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.
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