Swiss biopharmaceutical firm Auris Medical has concluded patient enrollment in a Phase III clinical trial (TACTT3) of its product candidate Keyzilen to treat acute and post-acute inner ear tinnitus.
More than 730 European patients have been recruited, with approximately 365 subjects each for the acute tinnitus stage (Stratum A) and the post-acute tinnitus stage (Stratum B).
Formulated in a biocompatible gel, Keyzilen is a small molecule antagonist of N-methyl-D-aspartate (NMDA) receptor currently being developed for delivery through intratympanic injection.
Reported to be involved in tinnitus occurrence, NMDA receptors’ continuous over-expression could result in pathologic excitation of auditory nerve fibres.
Auris Medical founder, chairman and CEO Thomas Meyer said: “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."
The randomised, double-blind, placebo-controlled Phase III trial will evaluate Keyzilen for the treatment of inner ear tinnitus after traumatic cochlear injury or otitis media.
The protocol for TACTT3 was amended based on the findings from previous Phase III TACTT2 trial.
The primary efficacy endpoints of the TACTT3 trial now include improvement of tinnitus loudness or in tinnitus functional index score.
It is expected that top-line results from the trial will be available in the first quarter of next year.
In addition to Keyzilen, Auris Medical is evaluating AM-111 for acute inner ear hearing loss, AM-101 to treat acute inner ear tinnitus and AM-125 for vestibular disorders such as Meniere's disease.