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.
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).
Dr. Thomas Meyer, Managing Director, telephone +41 61 201 13 50, firstname.lastname@example.org