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

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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.

Source: Auris Medical AG