EARS - Auris Medical reaches midpoint for enrollment in Part B of AM-125 study in peripheral vertigo
Auris Medical Holding (EARS) has reached the midpoint for enrollment in Part B of its Phase 2 proof-of-concept trial of AM-125 (intranasal betahistine) in the treatment of acute peripheral vertigo. In Part B of the TRAVERS trial, the Company will enroll 72 patients. 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.The Part A analysis had shown a positive dose-response relationship with active-treated patients performing up to 1.9 to 2.4 times better in the two key balance tests. The company looks forward to complete
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Auris Medical reaches midpoint for enrollment in Part B of AM-125 study in peripheral vertigo