Keyzilen: Ph III amended

Auris amended the protocol of the double-blind, placebo-controlled, European Phase III TACTT3 trial evaluating 3 intratympanic injections of 0.87 mg/mL Keyzilen given over 3-5 days to change the primary endpoint and include additional patients. The company will now use change in TFI to day 84 as an alternate primary endpoint instead of a secondary endpoint and will enroll an additional 120 patients to increase the trial's statistical power. The company amended the trial after Keyzilen missed the co-primary endpoints of improving subjective tinnitus loudness and tinnitus burden as measured by TFI at day 84 vs. placebo in the Phase III TACTT2 trial (see BioCentury, Aug. 22). However, Auris said data from TACTT2 also showed a reduction of 14.8 points in TFI from baseline for Keyzilen vs. a reduction of 6.2 points for placebo in the pre-specified subgroup of patients with tinnitus following otitis media...