Auris Medical Announces Publication Confirming Dose-Dependent Effects of Betahistine and Relationship to Bioavailability in Cat Model of Acute Vertigo


Zug, Switzerland, July 3, 2018 - Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and mental health supportive care, today announced the publication of an article confirming dose-dependent effects of betahistine and their relationship to bioavailability in a cat model of surgery-induced acute vertigo. The peer-reviewed article "Betahistine treatment in a cat model of vestibular pathology: pharmacokinetic and pharmacodynamic approaches" was published in Frontiers in Neurology, the second most-cited open-access journal in clinical neurology.[1]

The article presents the outcomes of a study with betahistine in a previously established model of acute loss of vestibular function in cats following the unilateral sectioning of the vestibular nerve (neurectomy). The immediate effect of this intervention is the loss of balance and the sensation of vertigo. Thanks to compensatory mechanisms, cats recover their vestibular function over around 40 days. The study demonstrated that daily oral administration of betahistine 2 mg/kg resulted in faster improvement of acute symptoms than with betahistine 0.2 mg/kg. In addition, unlike the lower dose, betahistine 2 mg/kg also accelerated significantly the recovery process; further, it was associated with a significant increase of the histaminergic activity of the tuberomamillary nuclei in the hypothalamus and substantially higher bioavailability in blood plasma (7 x relative to betahistine 0.2 mg/kg).

"We are very excited about the evidence from this study that confirms the benefits of increasing betahistine's bioavailability", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "This finding provides further support for our approach of using intranasal delivery of betahistine for treating acute vertigo. As previously reported, intranasal administration to healthy volunteers resulted in a 20- to 40-fold higher bioavailability compared with oral administration."

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 treatment of antipsychotic-induced weight gain and somnolence (AM-201). This program is currently in Phase 1. In addition Auris Medical has two Phase 3 programs under development: 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."

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[1] Tighilet B, Léonard J, Watabe I, Bernard-Demanze L, Lacour M (2018). Betahistine treatment in a cat model of vestibular pathology: pharmacokinetic and pharmacodynamic approaches. Front Neurol. 11(9):431.