Hamilton, Bermuda, April 25, 2019 (GLOBE NEWSWIRE) -- Auris Medical Holding Ltd. (NASDAQ:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today provided an update on its tinnitus drug development strategy. The Company intends to discuss and validate the protocol for a pivotal clinical trial with its late-stage investigational drug Keyzilen® (AM-101) with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) and to take the program forward through partnering or other types of non-dilutive funding.
The Company has completed the design of a new Phase 2/3 trial for its late-stage Keyzilen® program. The trial shall, in two stages, reaffirm the compound's efficacy in the treatment of acute tinnitus following traumatic cochlear injury and provide confirmatory efficacy data to support a filing for marketing authorization. It will incorporate learnings from the four late-stage trials, TACTT2, TACTT3, AMPACT1 and AMPACT2, notably with regard to the collection of patient reported outcomes and certain elements of study conduct. In addition, it will explore the use of a novel method for objective tinnitus diagnosis and measurement. The Company intends to discuss and validate the Phase 2/3 trial design with the FDA and EMA.
The Company aims to implement the further development of Keyzilen® as well as its early-stage tinnitus programs with non-dilutive funding. Funding options which are under consideration include: strategic partnering, special purpose vehicle financing, grant funding or a combination thereof.
"From the analysis of the large amounts of trial data and based on feedback from investigators as well as patients, we have gained a clear understanding of how to improve tinnitus measurement and trial conduct in a new pivotal study with Keyzilen®," stated Thomas Meyer, Auris Medical's founder, Chairman and CEO. "In addition, we expect the use of novel objective tinnitus diagnostics and measures to enhance patient selection and support patient reported outcomes. Given the strong unmet medical need among tinnitus sufferers worldwide, the positive data obtained with Keyzilen® from non-clinical studies as well as two Phase 2 trials and the two AMPACT trials, we remain committed to bringing this first-in-class therapy to patients. We look forward to our discussions with the regulatory agencies and to providing further updates on this promising program."
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 Keyzilen® / AM-101
Keyzilen® is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a biocompatible gel and delivered by intratympanic administration. Keyzilen® is in development for treatment of acute tinnitus following traumatic cochlear injury. Emerging evidence suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following acute traumatic injury to the inner ear. 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 biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and mental health supportive care. The company is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125) and for the prevention of antipsychotic-induced weight gain and somnolence (AM-201). These projects have gone through two Phase 1 trials and will move into proof-of-concept studies in 2019. In addition Auris Medical has two Phase 3 programs under development: Sonsuvi® (AM-111) for acute inner ear hearing loss and Keyzilen® (AM-101) for acute inner ear tinnitus. The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Auris Medical Holding Ltd. trade on the NASDAQ Capital Market under the symbol "EARS."
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 facts 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", or the negative of these terms or 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, Auris Medical's need for and ability to raise substantial additional funding to continue the development of its product candidates, the ability to pursue strategic partnering and non-dilutive funding for its Phase 3 programs Keyzilen
the results of Auris Medical's review of strategic options and the outcome of any action taken as a result of such review, 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 for the year ended December 31, 2018, and in Auris Medical's other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Auris Medical or to persons acting on behalf of Auris Medical are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. 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.
Edison Advisors for Auris Medical
646-653-7030 / 7719
Source: Auris Medical AG