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Auris Medical Completes Enrollment of TACTT2 Phase 3 Trial of AM-101 in Acute Inner Ear Tinnitus

Basel, Switzerland, March 30, 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 the Company has completed patient enrollment in the TACTT2 Phase 3 clinical trial of AM-101 in acute inner ear tinnitus. Top-line results from the TACTT2 trial are expected in August 2016.

"Completing enrollment of the pivotal TACTT2 trial represents an important corporate milestone for Auris Medical," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "AM-101 has the potential to be a first-in-class treatment for patients suffering from acute tinnitus and we look forward to the upcoming results from this trial."

The TACTT2 trial, which is being conducted primarily in North America, is a pivotal, randomized, double-blind, placebo-controlled trial in acute inner ear tinnitus following traumatic cochlear injury or otitis media. More than 330 patients were randomized to receive either AM-101 0.87 mg/mL or placebo in a 3:2 ratio. The primary endpoints are the change in tinnitus loudness from baseline to Day 84 and the change in the Tinnitus Functional Index total score. The trial is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration.

The second Phase 3 clinical trial of AM-101, TACTT3, which is being conducted in Europe, will enroll approximately 300 patients during the acute tinnitus stage (Stratum A) and approximately 330 patients during the post-acute tinnitus stage (Stratum B). Auris Medical expects to complete enrollment of the TACTT3 trial in a few months.

In the Phase 2 clinical trial program, AM-101 was well tolerated and demonstrated statistically significant improvements in tinnitus loudness, annoyance and impact as well as sleep difficulties for the AM-101 0.81 mg/mL dose compared to placebo at Day 90.

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 AM-101

AM-101 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 inner ear excitotoxicity, which is characterized by excessive synaptic release of glutamate, the principal neurotransmitter in the auditory system. Cochlear excitotoxicity may be triggered by exposure to excessive noise, neuroinflammation, disturbances in inner ear blood supply, or the administration of certain ototoxic drugs. It has been proposed that the upregulation of NMDA receptors induced by cochlear excitotoxicity is responsible for aberrant excitation of auditory nerve fibers, which is perceived as tinnitus. The development of AM-101 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 development of treatments for acute inner ear tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic injection 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.

Company contact: Cindy McGee, Head of Investor Relations and Corporate Communications, +41 61 201 1350, investors@aurismedical.com
Agency contact: Matthew P. Duffy, Managing Director, LifeSci Advisors, 212-915-0685, matthew@lifesciadvisors.com

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Source:Auris Medical AG