Auris Medical Holding (EARS) Achieves Mid-Point Patient Enrollment in Part B of AM-125 Phase 2 TRAVERS Trial in Acute Peripheral Vertigo
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Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders, today announced that it has reached the midpoint for enrollment in Part B of its Phase 2 proof-of-concept trial of AM-125 (intranasal betahistine) in the treatment of acute peripheral vertigo.
In Part B of the TRAVERS trial, the Company will enroll 72 patients who suffer from acute peripheral vertigo following neurosurgery. They are randomized to receive either 10 or 20 mg of intranasal betahistine or a placebo three times daily for four weeks. The improvement in the “Standing on Foam” test from baseline to Day 14 will be the primary efficacy endpoint; the improvement in the “Tandem Romberg” test to Day 42 (i.e. two weeks after completion of treatment) will be the key secondary efficacy endpoint. The two tests measure how long patients are able to maintain balance on a foam mat or with the two feet aligned one after the other, respectively, while they have their eyes closed. An interim analysis based on Part A of the TRAVERS trial had shown a positive dose-response relationship with active-treated patients performing up to 1.9 to 2.4 times better in the two key balance tests.
“We are very pleased to have reached this important interim milestone in the TRAVERS trial and to see recruitment rates recovering from the slow-down imposed by the second Covid-19 wave in recent months,” commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “We look forward to completing the TRAVERS trial later in 2021 and to advancing the AM-125 program further. Unlike other vertigo drugs that suppress the vestibular function to treat just short-term symptoms such as nausea, AM-125 acts as a vestibular stimulant to enhance and accelerate vestibular compensation and help patients to ‘get back on their feet’ more quickly. There is a strong medical need for a novel drug in this area, with e.g. 35.4% of the US population aged 40 years and older suffering from vestibular dysfunction (i.e. failing the ‘Standing on Foam’ test).”
The Company expects to complete enrollment into Part B of the TRAVERS trial by the end of the third quarter 2021, provided that the Covid-19 pandemic does not cause renewed restrictions on patient enrollment.
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. The compound has a very good safety profile, yet it is also known that its clinical utility is held back by poor oral bioavailability. Intranasal administration of betahistine has been shown to result in 5 to 29 times higher bioavailability.
Intranasal betahistine is being developed under project code AM-125 for the treatment of acute peripheral vertigo. Betahistine has been shown to increase cochlear, vestibular and cerebral blood flow, facilitate vestibular compensation and inhibit neuronal firing in the vestibular nuclei. 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.
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