Auris Medical submitting protocol amendment to regulatory agencies for TACTT3
Auris Medical Holding announced additional clinical data as well as updates to its development plan for Keyzilen in acute inner ear tinnitus. Based on insights from the recently completed TACTT2 trial, the Company is submitting a protocol amendment to regulatory agencies in Europe for TACTT3, the ongoing second Phase 3 clinical trial. In the amended trial 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 to enhance statistical sensitivity to the effects of treatment. Top-line results from the expanded TACTT3 trial are now expected in early 2018. The outcomes from TACTT2 and the regulatory path forward will be reviewed with the US Food and Drug Administration in early December 2016. TACTT2 was a randomized, double-blind, placebo-controlled trial conducted primarily in North America, enrolling 343 patients suffering from acute inner ear tinnitus following traumatic cochlear injury or otitis media. As previously announced, the trial failed to meet its two co-primary endpoints: the change in subjective tinnitus loudness and the change in tinnitus burden measured by the TFI from baseline to Day 84 over placebo. However, the TACTT2 trial data show treatment effects on TFI in favor of KeyzilenTM for specific subgroups. In the pre-specified subgroup of patients suffering from tinnitus following otitis media, treatment with KeyzilenTM resulted in a clinically meaningful and statistically significant reduction of 14.8 points in the TFI from baseline, as compared to 6.2 points for placebo (p=0.048). A reduction of 13 points was defined as clinically meaningful by the developers of the TFI. A trend for improvement was also observed in active-treated patients who suffered from severe or extreme tinnitus at baseline with a clinically meaningful reduction in TFI of 15.5 points as compared to 11.5 points in the placebo group (p=0.238). Unexpectedly, the TLQ showed a lower sensitivity to change than the TFI, which the Company believes to be related to the frequent rating of tinnitus loudness over an extended period of time.