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Auris Medical AG Receives IND Approval from FDA to Start Clinical Trial With AM-101  
11/24/2010 11:05:55 AM

November 23, 2010 -- Auris Medical announced today that it has received approval for its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to start a clinical trial with AM-101 in the USA. AM- 101 is a small molecule NMDA receptor antagonist under development for the local treatment of acute inner ear tinnitus. The phase II clinical trial under the title “Comparison of Single versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus (TACTT1)” will be conducted to evaluate the optimum dosing regimen for AM-101 as well to generate additional pharmacokinetic data.

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.

A first clinical trial with AM-101 (phase I/II) showed that intratympanically injected AM-101 was well toler- ated by study participants, and provided the first indications of therapeutic efficacy. A large double-blind, randomised, placebo-controlled phase IIb clinical trial with AM-101 is currently under way in Germany, Belgium, Poland and the Netherlands to further evaluate the treatment’s efficacy and safety. Patient enrol- ment in the study is expected to be completed during the first quarter of 2011.

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 acute sensorineural hearing loss (AM-111).

Contact:

Dr. Thomas Meyer, Managing Director, telephone +41 61 201 13 50, tm@aurismedical.com


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