Zug, Switzerland, March 10, 2015 - Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced the completion of the planned interim analysis in the post-acute tinnitus stratum of the TACTT3 trial ("Stratum B") with AM-101 and that enrollment could continue since the pre-specified futility threshold was not reached. Based on recommendations by the Independent Data Review Committee, the inclusion criteria will be adapted in order to focus on the early post-acute stage where higher levels of activity were observed than at the later stage. Accordingly, Stratum B will continue to enroll patients with tinnitus having started between 3 and 6 months prior and stop enrollment of patients with onset 6 to 12 months prior. The TACTT2 trial and Stratum A of TACTT3, which enroll patients with tinnitus up to 3 months from onset and were not part of the interim analysis, will continue unchanged.
The interim analysis on Stratum B of the randomized, double-blind, placebo-controlled European TACTT3 trial was performed based on 150 study participants (50% of the planned total) completing their second follow-up visit on Day 35. Futility was assessed since AM-101 had never before been tested beyond the acute stage of tinnitus (up to 3 months from onset). The evaluation was based on the primary efficacy variable of the trial, improvement in subjective tinnitus loudness, as well as on improvement in the Tinnitus Functional Index.
"We are very encouraged about the positive outcome from the interim analysis and look forward to continuing Stratum B to explore AM-101's therapeutic benefits in the post-acute stage", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. He added: "The outcome lends further support to our approach of treating inner ear tinnitus early, while the symptom is still of peripheral rather than central character." Bettina Stubinski, Chief Medical Officer of Auris Medical, stated: "Although accumulating evidence points to the benefits of early treatment, therapeutic benefits may still be possible to achieve even at later stages. The full analysis of outcomes from Stratum B will provide us with important further insights into the therapeutic time window for AM-101 and the natural history of inner ear tinnitus."
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. It may be short and just 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 may be only a slight nuisance, but often it has a serious impact on the ability to sleep, relax, or concentrate, or it may lead to tiredness, irritation, nervousness, despair, frustration, or even depression. As of today, there exists neither a universal standard of care for acute inner ear tinnitus, nor a truly proven, effective treatment method.
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, for example, exposure to excessive noise, neuroinflammation, disturbances in inner ear blood supply (anoxia/ischemia), 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 of Montpellier, France. The clinical development of AM-101 was initiated by Auris Medical in 2007 and comprises three completed clinical trials to date. Currently, two pivotal trials with AM-101 are ongoing in North America and Europe (TACTT2 and TACTT3). In 2013, Auris Medical reached agreement with the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its pivotal TACTT2 study. 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 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 prospectus relating to its Registration Statement on Form F-1, as amended, 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: Dr. Thomas Meyer, Chairman and CEO, +41 41 729 71 94, ear@aurismedical.com
