Auris Medical (EARS) Updates on Keyzilen Development; Says TACTT3 Phase 3 Protocol Amended

October 11, 2016 6:37 AM EDT

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Auris Medical Holding (Nasdaq: EARS) announced additional clinical data as well as updates to its development plan for Keyzilen (AM-101) 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 (TFI) 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 (tinnitus loudness question; TLQ) 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 (daily) rating of tinnitus loudness over an extended period of time.

“Although we are disappointed that the TACTT2 trial failed to confirm the efficacy of KeyzilenTM in the overall study population, we feel very encouraged by the clinically meaningful reductions in tinnitus burden in two relevant subgroups,” commented Thomas Meyer, founder, Chairman and Chief Executive Officer of Auris Medical. “New knowledge gained from the TACTT2 trial allows us to make appropriate adjustments to the TACTT3 trial while we are still fully blinded to its outcomes. We believe that the measures outlined today will improve the probability of success of the TACTT3 trial for the entire study population as well as for key patient subgroups.”

TACTT3, which is being conducted in Europe, is a randomized, double-blind, placebo-controlled trial in acute and post-acute inner ear tinnitus following traumatic cochlear injury or otitis media. So far, the trial enrolled more than 300 patients during the acute tinnitus stage (Stratum A) and approximately 330 patients during the post-acute tinnitus stage (Stratum B). Under the amended trial protocol, the change in tinnitus loudness and in the TFI from baseline to Day 84 will both be alternate primary efficacy endpoints. Applying the Hochberg procedure, the two endpoints will be tested for the overall study population as well as for the subpopulations of patients with otitis media-related tinnitus or with severe tinnitus at baseline. In order to enhance the trial’s statistical power, 60 additional patients will be recruited in TACTT3 in each of Stratum A and Stratum B. The Company expects enrollment to resume in early 2017.

For more information on tinnitus symptoms and the patient experience, please click on this video link: []

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