Dive Brief:
- Auris Medical announced Tuesday plans to modify an ongoing Phase 3 TACTT3 clinical trial for Keyzilen, its drug candidate for treatment of acute inner ear tinnitus, after a previous trial failed to meet both of its co-primary endpoints.
- Following the Phase 2 failure, Auris said it would submit a protocol amendment to European regulators to elevate tinnitus functional index scores, currently a secondary goal in the TACTT3 study, to an alternate primary endpoint. The Swiss biopharma is banking on replicating efficacy seen among two subgroups in the earlier study.
- Auris now expects top-line results for TACTT3 by early 2018 and plans to enroll 60 additional patients into the study beginning next year.
Dive Insight:
Auris' Keyzilen, a NMDA receptor antagonist, is designed to combat the occurrence of tinnitus following acute injury to the inner ear. Despite falling short in the Phase 2 study, Auris believes the proposed changes will increase the likelihood of success in Phase 3.
Still, Keyzilen’s flaws were revealed when it missed its co-primary endpoints in the recent TACTT2. The drug couldn’t beat a placebo in reducing scores on the tinnitus loudness question and the overall tinnitus burden among patients.
While TACTT2 missed its objectives, Auris claimed a silver lining based on efficacy seen in two patient subgroups.
Treatment with Keyzilen resulted in clinically meaningful and statistically significant reduction of 14.8 points in the Tinnitus Functional Index from baseline among patients suffering from tinnitus following otitis media, compared to 6.2 points for placebo. A reduction of 13 points was defined as clinically meaningful.
Auris also touted efficacy seen in treated patients who had severe or extreme tinnitus, although those results were not statistically significant.
Results from the failed TACTT2 study are expected to be reviewed by the Food & Drug Administration in early December to determine a path forward, Auris said. Meanwhile, Auris will try to amend its Phase 3 study.
"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," said Thomas Meyer, CEO of Auris Medical. "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."
Tinnitus has a serious impact on patient ability to sleep or relax. There is no effective treatment currently on the market.