Auris Medical Completes Enrollment of Phase 3 TACTT3 Trial with Keyzilen in Acute and Post-Acute Inner Ear Tinnitus

  • Top-line results from TACTT3 trial expected in the fourth quarter
  • Data to complement results from TACTT2 trial that are expected in August

ZUG, Switzerland I June 28, 2016 I Auris Medical Holding AG (EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced that it has completed patient enrollment in the Phase 3 TACTT3 clinical trial with KeyzilenTM (AM-101) in acute and post-acute inner ear tinnitus. Top-line results from the TACTT3 trial are expected in the fourth quarter of 2016.

"Our Phase 3 clinical trial program for KeyzilenTM, which is comprised of TACTT2 and TACTT3, is now fully enrolled with nearly 1,000 patients," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "KeyzilenTM has the potential to become the first-in-class treatment for acute inner ear tinnitus, a condition that can have a significant impact on patient health and well-being. We look forward to the upcoming results from these trials."

TACTT3, which is being conducted in Europe, is a randomized, double-blind, placebo-controlled Phase 3 trial in acute and post-acute inner ear tinnitus following traumatic cochlear injury or otitis media. The trial has enrolled more than 300 patients during the acute tinnitus stage (Stratum A) and approximately 330 patients during the post-acute tinnitus stage (Stratum B). The primary endpoint is the change in tinnitus loudness from baseline to Day 84. The change in the Tinnitus Functional Index, which measures tinnitus burden, is a secondary efficacy outcome.

The first Phase 3 clinical trial of KeyzilenTM, TACTT2, which is being conducted primarily in North America, enrolled over 300 patients during the acute tinnitus stage. The last study participant recently completed the last study visit, and Auris Medical expects to announce top-line results from the TACTT2 trial in August 2016.

In the Phase 2 clinical trial program, KeyzilenTM was well tolerated and demonstrated a statistically significant, dose dependent reduction in tinnitus loudness, tinnitus annoyance, sleep difficulties as well as overall tinnitus burden compared to placebo.

About Acute Inner Ear Tinnitus

Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various ear or other diseases. Inner ear tinnitus may be provoked by various injuries to the cochlea, the organ of hearing, such as overexposure to noise or inflammation. Tinnitus may be transitory; however, it may also become permanent. Tinnitus of less than three months of duration is considered acute, while older tinnitus is considered chronic. Inner ear tinnitus often has a serious impact on the ability to sleep, relax, or concentrate, and it may lead to tiredness, irritation, nervousness, despair, frustration, or even depression. As of today, neither a universal standard of care for acute inner ear tinnitus, nor a truly proven and effective treatment method is available.

About KeyzilenTM (AM-101)

KeyzilenTM is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a biocompatible gel for intratympanic injection. 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 KeyzilenTM 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 otolaryngology. The Company is currently focusing on the Phase 3 development of treatments for acute inner ear tinnitus (KeyzilenTM; AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic administration with biocompatible gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of the parent company Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol "EARS."

SOURCE: Auris Medical

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