Auris Medical Announces Closing of Two US Patent Acquisitions Related to the Use of Betahistine for the Treatment of Depression and ADHD

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Hamilton, Bermuda, May 15, 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 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 H 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 years and 4.4% of the adult population. 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). 

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.  Data from two clinical trials with oral betahistine provide initial evidence for therapeutic benefits in depression.

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.

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.”

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Globe Newswire: 14:00 GMT Wednesday 15th May 2019

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