Auris Medical Highlights Publication of Study Results Demonstrating Betahistine’s Antiepileptogenic and Anticonvulsant Activity in Murine Model


Hamilton, Bermuda, February 25, 2020 - Auris Medical Holding AG (NASDAQ: 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 publication of an article describing the anti-epileptic and anti-convulsive activity of betahistine in a mouse model. The peer-reviewed article titled “Betahistine prevents kindling, ameliorates the behavioral comorbidities and neurodegeneration induced by pentylenetetrazole” was recently published in Epilepsy & Behavior, a fast growing international journal covering behavioral aspects of seizures and epilepsy.1

The article was written by an independent Iranian research group and presents the outcomes of a study on the effects of betahistine on seizure scores, memory deficits, depression, and neuronal loss in a murine model of epilepsy. Seizure was induced by treatment with pentylenetetrazole (PTZ), a common protocol in epilepsy studies. The researchers found that pretreatment and repetitive treatment with intraperitoneal betahistine entirely prevented generalized tonic-clonic seizures induction and significantly diminished seizure intensity. Further, it decreased cell death in the hippocampus and cortex, suggesting a neuroprotective effect of betahistine, and ameliorated the memory deficit and depression induced by PTZ in the kindled animals.

“The exciting outcomes from this study supplement results from earlier studies which showed that an increase in central histamine level suppresses convulsion activity and provides neuroprotection,” commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “Importantly, they also suggest further potential therapeutic uses for betahistine. While betahistine is currently approved and used world-wide for the treatment of vertigo, there is a growing body of evidence that the drug also enhances learning, cognitive function, atypical depression, or wakefulness, and reduces antipsychotic-induced weight gain. With our AM-125 project, we are targeting the vertigo indication with an intranasal formulation of betahistine that provides significantly higher plasma exposure than the current oral formulation, and with our AM-201 project, we are targeting antipsychotic-induced weight gain and somnolence and have started to expand into other therapeutic areas.”

About Betahistine

Betahistine is a small molecule structural analog of histamine, which acts as an agonist at the H1 and as an antagonist at the H3 histamine receptors. Unlike histamine, it crosses the blood-brain-barrier. It is known to enhance inner ear and cerebral blood flow, increase histamine turnover and enhance histamine release in the brain, increase release of acetylcholine, dopamine and norepinephrine in the brain and to result in general brain arousal. Betahistine for oral administration is approved in about 115 countries, with the US being a notable exception, for the treatment of vertigo and Meniere’s disease. The compound has a very good safety profile, yet it is also known that its clinical utility is held back by poor bioavailability. Intranasal administration of betahistine has been shown to result in 5 to 29 times higher bioavailability.

About Auris Medical

Auris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and CNS disorders. 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 moved 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.”

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, 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.

Investor contact:
Joseph Green
Edison Advisors for Auris Medical
646-653-7030
jgreen@edisongroup.com

Or

investors@aurismedical.com




1 Yazdi A et al. (2020), Betahistine prevents kindling, ameliorates the behavioral comorbidities and neurodegeneration induced by pentylenetetrazole, Epilepsy Behav 105: 106956.