HAMILTON, BERMUDA – Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, announced that the first patient has been randomized in Part B of its “TRAVERS” Phase 2 trial of AM-125 (intranasal betahistine) in acute vertigo.
This follows the positive read-out from the interim analysis on Part A of the study in early September 2020, the completion of enrollment into the oral treatment group, and the receipt of regulatory clearance for Part B in the first three of the participating study countries.
TRAVERS Trial for Acute 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. With Part B, we aim to confirm these positive outcomes with the two highest doses in a larger patient sample and, based on those results, advance the program into Phase 3 development. For patients suffering from vertigo, regaining balance as quickly as possible is of utmost importance. 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’.”
–Thomas Meyer, Auris Medical’s founder, Chairman and CEO
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.
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, in Phase 2) and for the prevention of antipsychotic-induced weight gain and somnolence (AM-201, post Phase 1b). With AM-301, the Company is developing a nasal spray for protection against airborne pathogens and allergens. 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