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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, June 28, 2016 (GLOBE NEWSWIRE) -- 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 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."

Forward-looking Statements

This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or Auris Medical's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the timing and conduct of clinical trials of Auris Medical's product candidates, the clinical utility of Auris Medical's product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical's intellectual property position and Auris Medical's financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical's capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Auris Medical's Annual Report on Form 20-F and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

Contact: Cindy McGee, Head of Investor Relations and Corporate Communications, +41 61 201 1350, investors@aurismedical.com

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Source:Auris Medical AG