EARS Auris Medical Holding AG

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 announced the successful closing of the purchase of two US patents related to the use of betahistine for the treatment of depression and attention-deficit / hyperactivity disorder (ADHD). The Company acquired full ownership of the US patents 8,119,668 and 8,242,148, “Treatment methods employing histamine H3 receptor antagonists, including betahistine,” with key claims directed towards the treatment of depression and ADHD, respectively.

“We are very pleased to add two more patents to our growing portfolio of betahistine related intellectual property, which now comprises five issued US patents,” commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “ADHD and atypical depression are frequent mental disorders that can have a substantial impact on an individual’s day-to-day function and quality of life. Based on betahistine’s mechanism of action and supportive preliminary data, we expect it to offer therapeutic benefits also in the treatment of these two conditions. The magnitude of such benefits will potentially be further augmented by our intranasal delivery approach, which provides significantly higher bioavailability compared to the currently established oral delivery approach.”

In the US, ADHD is estimated to affect 8.8% of children between the ages of 4-17 years1 and 4.4% of the adult population.2 The disorder manifests with symptoms such as hyperactivity, impulsivity and inattention. As demonstrated by the two inventors in a study with 16 adult ADHD patients, treatment with a high dose of oral betahistine resulted in a statistically significant improvement in surrogate markers for cognitive outcomes, attentional sensitivity in the Continuous Performance Task and inhibition in the Go/No-Go task, compared to placebo (p=0.02 and 0.004).3 

Atypical depression is a subtype of major depression. It is characterized by mood reactivity, fatigue, excessive somnolence, increased appetite or weight gain and cognitive deficits. Estimates in both community and clinical settings suggest that 15.7% to 36.6% of patients with depression present with atypical features.4  Data from two clinical trials with oral betahistine provide initial evidence for therapeutic benefits in depression.5,6

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 admin-istration 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 4 to 26 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 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.”

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 Visser et al. (2014), Trends in the parent-report of health care provider diagnosed and medicated attention-deficit/hyperactivity disorder: United States, 2003-2011. J Am Acad Child Adolesc Psychiatry 53(1):34-46.

2 Kessler et al. (2006), The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Am J Psychiatry 163(4):716-723.

3  Moorthy et al. (2015), Safety, tolerability and pharmacokinetics of 2-pyridylacetic acid, a major metabolite of betahistine, in a phase 1 dose escalation study in subjects with ADHD. Biopharm. Drug Dispos. 36:429-439.

4 For a review see e.g. Cristancho et al. (2011), Atypical depression in the 21st century: diagnostic and treatment issues. Psychiatric Times 28[1]:42-47.

5 Morozova et al. (2015), Effects and safety profile of betahistine in patients in the Russian contingent of OSVaLD, an open-label observational study in vestibular vertigo. Int J Gen Med. 8:47-53.

6 Barak et al. (2016), A randomized, double-blind, placebo-controlled pilot study of betahistine to counteract olanzapine-associated weight gain. J Clin Psychopharmacol. 36(3):253-6.