Auris Medical completes enrolment in tinnitus treatment trial

Auris Medical completes enrolment in tinnitus treatment trial

February 2010

Auris Medical announced today that enrolment has been completed for its phase IIb clinical trial with AM-101 for the treatment of acute inner ear tinnitus. A total of 252 patients were enrolled in the study to re-ceive 3 intratympanic injections of either AM-101 at 0.27 or 0.81 mg/ml or placebo. The study recruited patients suffering from persistent inner ear tinnitus due to acute acoustic trauma, sudden deafness or otitis media not more than 3 months from onset.

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 disruptions in its blood supply. 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 tinnitus that is older than one year 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 depres-sion. As of today, there exists neither a universal standard of care for acute inner ear tinnitus, nor a truly proven, effective treatment method.

About AM-101

AM-101 contains a small molecule that selectively blocks N-methyl-D-aspartate (NMDA) receptors. Emerg-ing evidence suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following inner ear excitotoxicity, which is characterized by excessive synaptic release of glutamate, the principal neurotransmitter in the auditory system. Cochlear excitotoxicity may be triggered by, for example, exposure to excessive noise, disturbances in inner ear blood supply (anoxia/ischemia), barotrauma, migration of pathogens from the inflamed middle ear into the inner ear, noise/vibration trauma resulting from middle ear surgery, or the administration of certain ototoxic drugs. It has been hypothesized that the upregulation of NMDA receptors induced by cochlear excitotoxicity is responsible for abnormal spontaneous “firing” of auditory nerve fibres, which is perceived as tinnitus.

AM-101 was clinically evaluated for the first time in a phase I/II study in 2007/08, which showed that the treatment was well tolerated and safe. The trial also provided some first indications of therapeutic efficacy. This was followed by a much larger phase IIb clinical trial that was conducted in Germany, Belgium, Poland and the Netherlands and that involved more than 240 patients. Results from this study are expected to be released in the second half of 2011. A third study (TACCT1) is about to start in the USA.

About Auris Medical

Auris Medical is a Swiss biotechnology company developing specific pharmaceutical compounds for the prevention or treatment of inner ear disorders, an area of great unmet medical need. Around the world, many million people are suffering permanently from severe hearing loss and / or tinnitus, still lacking truly effective and safe treatments for their disorders. Auris Medical is currently focusing on the development of treatments for acute inner ear tinnitus (AM-101) and for acutesensorineural hearing loss (AM-111).