February 13, 2013 -- Auris Medical announced today that enrolment has been completed for its TACTT11
study, a phase II clinical
trial with AM-101 for the treatment of acute peripheral tinnitus. A total of 85 patients were enrolled in the
study to receive either AM-101 at 0.81 mg/mL or placebo. In Stage 1 of the trial, a single dose intratympanic
injection was administered, while in Stage 2 each study subject received a total of 3 intratympanic injec-
tions over 2 weeks. The study recruited patients suffering from tinnitus following acute noise trauma, inner
ear barotrauma, middle ear surgery or otitis media up to 3 months after onset. Results from the TACTT1
study, which is being conducted in the USA, Belgium, Germany and Poland, are expected to become avail-
able in summer 2013.
About acute peripheral tinnitus
Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various
ear or other diseases. Peripheral tinnitus may be provoked by various injuries to the peripheral auditory
system. The cochlea, the organ of hearing, may e.g. be injured by overexposure to noise or disruptions in its
blood supply. The tinnitus may be short and just transitory; however, it may also become permanent. Tinni-
tus of less than three months of duration is considered acute, while tinnitus that is older than one year is
Peripheral 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 peripheral 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,
trauma (e.g. exposure to excessive noise), neuroinflammation, disturbances in inner ear blood supply, or the
administration of certain ototoxic drugs. It has been hypothesized that the upregulation of NMDA receptors
induced by cochlear excitotoxicity is responsible for aberrant excitation of auditory nerve fibres, which is
perceived as tinnitus.
The development of AM-101 is based on research conducted at the INSERM Institute for Neurosciences of
Montpellier, France. The clinical development of AM-101 was initiated by Auris Medical in 2007. Patents
have been granted in more than 30 countries worldwide to date.
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 permanently suffering from severe hearing loss and tinnitus. Truly effective and
safe treatments for these disorders are still lacking. Auris Medical is currently focusing on the development
of treatments for acute peripheral 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