ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced disappointing results from its TACTT3 clinical trial for its promising tinnitus drug candidate, Keyzilen. Preliminary top-line data from the trial indicate that the study did not provide a statistically significant improvement in the Tinnitus Functional Score from baseline to Day 84 in the active treated group compared to placebo.
The company’s investigative drug, Keyzilen, is an esketamine gel for intratympanic injection, intended for acute peripheral tinnitus following cochlear injury or otitis media in adults. The drug received Fast Track designation from the FDA last year, which helps expedite the review process.
Value of the company’s stock dropped drastically this week, following the news.
Pharmaceutical Treatment of Hearing Loss and Tinnitus
Several startup companies, including those backed by major pharmaceutical companies, are focused on discovering ways to treat hearing loss, tinnitus and other ear-related disorders. As much promise has been shown in potential drug treatments or therapies to treat these disorders, researchers face many challenges to developing an effective treatment.
The failure of the Keyzilen tinnitus drug is, unfortunately, not the first disappointment for Auris Medical. In the fall of 2017, just weeks after Otonomy announced that it was cutting staff and suspending further clinical trials due to poor results from its Meniere’s drug trial, the company announced that it was terminating a late-stage study to treat sudden sensorineural hearing loss (SSNHL) with its investigational drug, AM-111.
With the company’s share price under significant pressure, Auris shareholders held an extraordinary general meeting on March 12 and it was agreed that the company will merge with one of its subsidiaries, resulting in a stock split. Auris said in a statement that will be investigating the outcomes, including those in a previously conducted TACTT2 trial, and will provide an update soon.
Source: Auris Medical