Auris Med Completes Patient Recruitment For Phase III TACTT3 Trial Of Keyzilen In Acute And Post-Acute Tinnitus

Published: Sep 22, 2017

  • Trial now includes more than 730 patients under previously announced amended protocol
  • Top-line results from TACTT3 expected in first quarter 2018
  • Zug, Switzerland, September 22, 2017 - Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today 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. 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," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "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 the trial size was increased.

    About Acute Inner Ear Tinnitus

    Tinnitus is the perception of sound without external acoustic stimulation. Tinnitus of the inner ear may be caused by various injuries to the cochlea, the organ of hearing, such as overexposure to noise. Tinnitus that has been present for less than three months is considered acute, while tinnitus that has been present for over three months is considered chronic. Tinnitus of the inner ear often has a serious impact on ability to sleep, relax or concentrate, which may lead to tiredness, irritation, anxiety or depression. There is no universal standard of care for tinnitus of the inner ear and efficacy of a pharmacological treatment for tinnitus of the inner ear has not yet been conclusively demonstrated.

    About Keyzilen® (AM-101)

    Keyzilen® is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a biocompatible gel and delivered by intratympanic injection. Keyzilen® is in development for treatment of acute tinnitus of the inner ear. Emerging evidence suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following acute injury to the inner ear, e.g. from exposure to excessive noise, infections, disturbances in inner ear blood supply, or the administration of certain ototoxic drugs. Persistent overexpression of NMDA receptors may lead to pathologic excitation of auditory nerve fibers, which in the brain is perceived as tinnitus. The development of Keyzilen® is based on research conducted at the INSERM Institute for Neurosciences, and patents have been granted in more than 40 countries worldwide so far.

    About Auris Medical

    Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology. The company is focused on the Phase 3 development of treatments for acute inner ear hearing loss (AM-111) and for acute inner ear tinnitus (Keyzilen®; AM-101) by way of intratympanic administration with biocompatible gel formulations. In addition, Auris Medical is developing intranasal betahistine for Meniere's disease and other vestibular disorders (AM-125) as well as early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol "EARS."

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