Auris Medical Announces Publication of New Data Highlighting the Role of Betahistine in Promoting the Restoration of Forgotten Memories in Mice and Healthy Volunteers

Zug, Switzerland, January 23, 2019 - 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 advance publication of an article demonstrating that betahistine promotes the retrieval of forgotten memories in mice and in healthy human volunteers. The peer-reviewed article titled "Central histamine boosts perirhinal cortex activity and restores forgotten object memories" is currently in print in Biological Psychiatry, one of the most highly cited journals in the field of psychiatric neuroscience.^[1]

The article was written by an independent Japanese research group and presents the outcomes of a study on the role of histamine in the recollection of forgotten memories and the effects of using histamine H₃ receptor inverse agonists for treatment. In the first part of the study, the authors demonstrated in mice that treatment with betahistine or thioperamide induced the recall of forgotten memories of certain objects one week or one month later. They showed that the memory recovery was promoted by the H₃ receptor inverse agonists through upregulation of histamine release in the brain, the following activation of histamine H₂ receptors and increased spontaneous activity in perirhinal cortex neurons.

In the second part of the study, 38 healthy adult volunteers were enrolled in a randomized double-blind, placebo-controlled crossover trial. At baseline, they were shown 128 pictures of objects. Seven days after the training, they were shown again 32 of these objects, randomly mixed with 32 new objects and 32 objects that were similar, but not identical to previously shown images, and asked to decide whether each image was "old", "new" or "similar". Thirty minutes prior to the test, they received in a single dose either 108 mg betahistine mesilate, (i.e. three times the approved daily oral dose) or placebo. The test was repeated two days later, with different images, and with active-treated participants switching over to placebo and vice versa. Treatment with betahistine overall improved the percentage of correct memories (p<0.05), enhanced the retrieval of more difficult items and benefited participants with poor performance under placebo treatment (p<0.01).   

"The exciting outcomes from this study add to the growing body of evidence supporting the important role of histamine in the acquisition, storage and retrieval of memory and suggest further potential uses for betahistine," commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "Histamine plays a key role in the regulation of a wide range of behavioral and physiological functions, including appetite, drinking, sleep, wakefulness, learning, attention and memory. Earlier studies with betahistine already showed positive effects on learning and cognitive function. While betahistine's clinical utility has been limited by poor bioavailability when administered orally, our intranasal formulation allows for significantly higher plasma exposure, which is expected to translate into better therapeutic outcomes and open up new therapeutic uses."

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 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 Zug, Switzerland. The shares of Auris Medical Holding AG trade on the NASDAQ Capital Market under the symbol "EARS."

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^[1] Nomura H et al. Central histamine boosts perirhinal cortex activity and restores forgotten object memories. Biol Psychiatry. In press.