ZUG, Switzerland, March 10, 2015 (GLOBE NEWSWIRE) -- Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced the completion of the planned interim analysis in the post-acute tinnitus stratum of the TACTT3 trial ("Stratum B") with AM-101 and that enrollment could continue since the pre-specified futility threshold was not reached. Based on recommendations by the Independent Data Review Committee, the inclusion criteria will be adapted in order to focus on the early post-acute stage where higher levels of activity were observed than at the later stage. Accordingly, Stratum B will continue to enroll patients with tinnitus having started between 3 and 6 months prior and stop enrollment of patients with onset 6 to 12 months prior. The TACTT2 trial and Stratum A of TACTT3, which enroll patients with tinnitus up to 3 months from onset and were not part of the interim analysis, will continue unchanged.
The interim analysis on Stratum B of the randomized, double-blind, placebo-controlled European TACTT3 trial was performed based on 150 study participants (50% of the planned total) completing their second follow-up visit on Day 35. Futility was assessed since AM-101 had never before been tested beyond the acute stage of tinnitus (up to 3 months from onset). The evaluation was based on the primary efficacy variable of the trial, improvement in subjective tinnitus loudness, as well as on improvement in the Tinnitus Functional Index.
"We are very encouraged about the positive outcome from the interim analysis and look forward to continuing Stratum B to explore AM-101's therapeutic benefits in the post-acute stage", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. He added: "The outcome lends further support to our approach of treating inner ear tinnitus early, while the symptom is still of peripheral rather than central character." Bettina Stubinski, Chief Medical Officer of Auris Medical, stated: "Although accumulating evidence points to the benefits of early treatment, therapeutic benefits may still be possible to achieve even at later stages. The full analysis of outcomes from Stratum B will provide us with important further insights into the therapeutic time window for AM-101 and the natural history of inner ear tinnitus."
About acute inner ear tinnitus
Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various ear or other diseases. (Inner ear tinnitus may be provoked by various injuries to the cochlea, the organ of hearing, such as overexposure to noise or inflammation. It may be short and just transitory; however, it may also become permanent. Tinnitus of less than three months of duration is considered acute, while older tinnitus is considered chronic.
Inner ear tinnitus may be only a slight nuisance, but often it has a serious impact on the ability to sleep, relax, or concentrate, or it may lead to tiredness, irritation, nervousness, despair, frustration, or even depression. As of today, there exists neither a universal standard of care for acute inner ear tinnitus, nor a truly proven, effective treatment method.
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