Auris Medical Holding AG (NASDAQ:EARS) soared 39.32% or +1.51 points during previous trade after opening at the price of $4.45, a total of 3.21M shares exchanged hands compared with its average trading volume of 129,055.00 shares.
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Keyzilen did not produce significant changed in tinnitus loudness and tinnitus burden when compared to patients who received a placebo.
TACTT2 was designed as a randomized, double-blind, placebo-controlled trial in acute inner ear tinnitus following traumatic cochlear injury or otitis media. It was conducted in the USA, and included 343 patients, who received either Keyzilen 0.87 mg/mL or placebo in a ratio of 3:2. The co-primary endpoints were the improvement in subjective tinnitus loudness from baseline to Day 84 and the improvement in tinnitus burden from baseline to Day 84, measured by the Tinnitus Functional Index (TFI). The tests revealed that the Keyzilen didn’t show any statistical difference in tinnitus improvement against the placebo for either endpoint. The trial’s primary safety endpoint, incidence of clinically meaningful hearing deterioration, was low with no statistically significant difference from the placebo group, supporting the safety profile of Keyzilen.
TACTT3, which is being conducted in Europe, is a randomized, double-blind, placebo-controlled trial in patients with acute and post-acute inner-ear tinnitus after traumatic cochlear injury or otitis media.
Small cap Auris Medical Holding has missed its co-primary endpoints in a key Phase III trial after it failed to beat placebo in treating patients with tinnitus. “We plan to complete this analysis and meet with the regulatory agencies prior to the TACTT3 readout, which is expected in the fourth quarter”, Chief Executive Thomas Meyer said in a statement. It has enrolled more than 300 patients for acute tinnitus stage, and nearly 330 patients for the post-acute tinnitus stage. There is no effective treatment.
AM-101 contains esketamine hydrochloride, an N-Methyl-D-aspartate (NMDA) receptor antagonist. Its advanced product candidate, AM-101, is in Phase III clinical development for acute inner ear tinnitus under a special protocol assessment (SPA) from the United States Food and Drug Administration. Persistent overexpression of NMDA receptors may lead to pathologic excitation of auditory nerve fibers, which in the brain is perceived as tinnitus. The biotech wants Keyzilen to become the first drug to gain approval for treating acute inner ear tinnitus, but this failure will be a major setback for the company. Auris Medical Holding AG has a 52-week low of $1.95 and a 52-week high of $7.96. Its second product candidate, AM-111, is being developed for the treatment of acute sensorineural hearing loss (ASNHL).
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Auris Medical Holding AG (NASDAQ:EARS) reached at $5.35 price level during last trade its distance from 20 days simple moving average is 30.58%, and its distance from 50 days simple moving average is 34.63% while it has a distance of 34.66% from the 200 days simple moving average.
