Auris Medical Holding AG (NASDAQ: EARS), a Swiss-based biopharmaceutical company dedicated to developing therapeutics that address unmet medical needs in otolaryngology, announced that it has completed the recruitment of patients for the Phase 3 TACTT3 clinical trial of Keyzilen® in acute and post-acute inner ear tinnitus. Keyzilen® is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonistin that is in development for treatment of acute tinnitus of the inner ear, according to Auris. Keyzilen is designed based on “emerging evidence” that overexpression of NMDA receptors in the cochlea after acute injury may lead to pathologic excitation of auditory nerve fibers, which, in the brain, is perceived as tinnitus, according to the company’s announcement. The trial enrolled more than 365 patients during both the acute tinnitus stage (Stratum A) and the post-acute tinnitus stage (Stratum B). Top-line results from the TACTT3 trial are expected in the first quarter of 2018.
“We are pleased to complete the recruitment of patients for TACTT3, our pivotal trial with Keyzilen® in Europe,” said Thomas Meyer, Auris Medical’s founder, chairman and CEO. “Keyzilen® has the potential to become the first specific pharmacological treatment for patients with inner ear tinnitus and we look forward to announcing top-line results from TACTT3 early next year.”
TACTT3 is a randomized, double-blind, placebo-controlled Phase 3 trial in inner ear tinnitus following traumatic cochlear injury or otitis media. As previously announced, the TACTT3 protocol was amended based on analysis of the TACTT2 Phase 3 trial outcomes. The primary efficacy endpoints for the trial include either the improvement of tinnitus loudness or improvement in Tinnitus Functional Index score. In addition, the amended protocol includes certain patient subgroups in confirmatory statistical testing and increased trial size.
Source: Auris Medical Holdings