On Thursday, Auris Medical Holding Ltd. (NASDAQ: EARS) reported topline data from its Phase 2 Travers trial with intranasal betahistine (AM-125) in vertigo. These results sent shares higher in morning trading.
Overall, the interim analysis of the topline data was positive, but it was only based on Part A of the trial that has 33 patients enrolled. These patients are suffering from vertigo following neurosurgery.
The study demonstrated a dose-dependent improvement in balance as well as good safety and tolerability of ascending doses of AM-125. At the highest dose, AM-125-treated patients improved their performance of the “Tandem Romberg” and the “Standing on Foam” balance tests from baseline to 14 days post-surgery (primary endpoint) on average 1.9 to 2.4 times more than placebo-treated patients.
In contrast to placebo, the improvement from baseline was statistically significant for AM-125. These positive results were supported by similar improvements in additional efficacy measures, including additional objective as well as clinician- and patient-reported outcomes.
Based on the results from the interim analysis, the two highest doses, 10 and 20 mg, were selected by the company to be tested against placebo in 72 patients in Part B of the trial.
Also, the improvement in the “Standing on Foam” test will become the sole primary efficacy endpoint. This test measures how long patients are able to maintain balance on a foam mat with their eyes closed, relying primarily on vestibular input from their inner ears.
The improvement in the more challenging “Tandem Romberg” test, which is performed with eyes closed and the two feet aligned one after the other, will become the key secondary efficacy endpoint.
Auris Medical stock traded up about 28% on Thursday, at $1.07 in a 52-week range of $0.65 to $3.20. The consensus price target is $14.95.
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