U.S. Markets close in 4 hrs 56 mins

Auris Medical Announces Publication of New Data Highlighting the Role of Betahistine in Promoting the Restoration of Forgotten Memories in Mice and Healthy Volunteers


Zug, Switzerland, January 23, 2019 - Auris Medical Holding AG (EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today highlighted the advance publication of an article demonstrating that betahistine promotes the retrieval of forgotten memories in mice and in healthy human volunteers. The peer-reviewed article titled "Central histamine boosts perirhinal cortex activity and restores forgotten object memories" is currently in print in Biological Psychiatry, one of the most highly cited journals in the field of psychiatric neuroscience.[1]

The article was written by an independent Japanese research group and presents the outcomes of a study on the role of histamine in the recollection of forgotten memories and the effects of using histamine H3 receptor inverse agonists for treatment. In the first part of the study, the authors demonstrated in mice that treatment with betahistine or thioperamide induced the recall of forgotten memories of certain objects one week or one month later. They showed that the memory recovery was promoted by the H3 receptor inverse agonists through upregulation of histamine release in the brain, the following activation of histamine H2 receptors and increased spontaneous activity in perirhinal cortex neurons.

In the second part of the study, 38 healthy adult volunteers were enrolled in a randomized double-blind, placebo-controlled crossover trial. At baseline, they were shown 128 pictures of objects. Seven days after the training, they were shown again 32 of these objects, randomly mixed with 32 new objects and 32 objects that were similar, but not identical to previously shown images, and asked to decide whether each image was "old", "new" or "similar". Thirty minutes prior to the test, they received in a single dose either 108 mg betahistine mesilate, (i.e. three times the approved daily oral dose) or placebo. The test was repeated two days later, with different images, and with active-treated participants switching over to placebo and vice versa. Treatment with betahistine overall improved the percentage of correct memories (p<0.05), enhanced the retrieval of more difficult items and benefited participants with poor performance under placebo treatment (p<0.01).   

"The exciting outcomes from this study add to the growing body of evidence supporting the important role of histamine in the acquisition, storage and retrieval of memory and suggest further potential uses for betahistine," commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "Histamine plays a key role in the regulation of a wide range of behavioral and physiological functions, including appetite, drinking, sleep, wakefulness, learning, attention and memory. Earlier studies with betahistine already showed positive effects on learning and cognitive function. While betahistine's clinical utility has been limited by poor bioavailability when administered orally, our intranasal formulation allows for significantly higher plasma exposure, which is expected to translate into better therapeutic outcomes and open up new therapeutic uses."

About Auris Medical

Auris Medical is a Swiss 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 Zug, Switzerland. The shares of Auris Medical Holding AG trade on the NASDAQ Capital 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 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, 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, 2017, 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.

Investor contact:
Joseph Green / Andrew Gibson
Edison Advisors for Auris Medical
646-653-7030 / 7719
jgreen@edisongroup.com / agibson@edisongroup.com

Or

investors@aurismedical.com




[1] Nomura H et al. Central histamine boosts perirhinal cortex activity and restores forgotten object memories. Biol Psychiatry. In press.