The phase IIb clinical trial with AM-101 will recruit patients suffering from persistent inner ear tinnitus following a documented acute acoustic trauma or sudden deafness incident less than 3 months before. Study participants will receive the medication injected into the middle ear under local anaesthesia of the ear drum. Intratympanic injections are a well established, minimally invasive procedure. Patients will be as-sessed for their tinnitus, hearing function and various other assessments over a three month period. The primary endpoint of the study will be the change in the tinnitus minimum masking level from baseline to day 90.
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 exposure to excessive noise such as in the case of acute or repeated acoustic trauma, sudden deafness, anoxia / ischemia, the administration of certain ototoxic drugs, middle ear infections or various other inner ear injuries. 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 NMDA receptors. Based on research conducted at the INSERM Institute for Neurosciences of Montpellier, France, NMDA receptors in the cochlea can provoke aberrant activity of the auditory nerve which is perceived as tinnitus. NMDA receptors do not seem to be involved in fast excitatory neurotransmission which is essential for hearing, but may be activated following some excitotoxic incident such as noise trauma or sudden deafness. It had been demonstrated in behav-ioural and electrophysiological models that local administration of the NMDA antagonist AM-101 to ani-mals suffering from tinnitus effectively suppressed the perception of the “phantom sound”.
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 inner ear tinnitus (AM-101) and for acute sensorineural hearing loss (AM-111).
