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Auris Medical Announces Completion of Enrollment into First Part of TRAVERS Phase 2 Study with AM-125 in Vertigo
- Dose escalation completed as last patient enrolled into Part A of TRAVERS study
- Interim results to be announced in Q3 of 2020
In Part A of the TRAVERS trial, three ascending doses of AM-125 or placebo, administered three times daily over a total of four weeks, will be tested in a total of 30 patients. The primary endpoint will be the improvement of vestibular function from baseline to Day 14. This is assessed by measuring for how long patients are able to maintain their balance with eyes closed – once while standing on foam, and once while doing the tandem Romberg test, which requires the two feet to be aligned one after the other. The results from the interim analysis will inform the selection of two doses for further testing against placebo in an estimated 72 patients in Part B of the trial. While the interim analysis will be carried out and prior to starting Part B, open label testing of oral betahistine for reference purposes will be completed (n=16).
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