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Auris Medical Announces Initiation of Part B of TRAVERS Phase 2 Study with AM-125 in Vertigo
In Part B of the TRAVERS trial, the Company will enroll 72 patients who suffer from acute vertigo following neurosurgery. They will be 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. As the Company remained blinded to treatment allocation during the interim analysis, the corresponding data from Part A will be pooled with those from Part B.
“In Part A of the TRAVERS trial, we demonstrated good safety and tolerability of AM-125 and observed a compelling dose response effect with active treated patients, showing up to 1.9 to 2.4 times better performance in key balance tests,” commented
The Company expects to complete enrollment into Part B of the TRAVERS trial by the end of the first quarter 2021, provided that the Covid-19 pandemic does not cause further 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 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 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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Source: Auris Medical AG