Auris Medical Holding Ltd., a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, announced the completion of patient enrollment into Part A of its Phase 2 “TRAVERS” trial with intranasal betahistine in vertigo (AM-125).
The company says that it expects to release interim results from TRAVERS and commence Part B of the trial in the coming weeks.
“Thanks to a quicker than expected recovery of study activities following the COVID-19 outbreak, we are very pleased to announce the completion of enrollment into Part A of TRAVERS. We look forward to analyzing the interim results and anticipate further improvement in recruitment rates as we will begin Part B of TRAVERS.”
–Thomas Meyer, Auris Medical’s founder, Chairman and CEO
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.
About Auris Medical
Auris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and CNS disorders. 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 moved 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 Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Auris Medical Holding Ltd. trade on the NASDAQ Capital Market under the symbol “EARS.”
Source: Auris Medical