Hamilton, Bermuda, October 13, 2020 – 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, today 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.
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 Thomas Meyer, Auris Medical's founder, Chairman and CEO. "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'."
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.