January 17, 2011 – Auris Medical starting enrolment in second cohort of phase IIb study with
AM-111. Auris Medical announced today that enrolment has started for the second dose cohort in its phase IIb clini-
cal trial with AM-111 for the treatment of acute sensorineural hearing loss (ASNHL). It is planned to enrol
slightly more than 100 patients in the cohort. Study participants will receive either AM-111 at 0.4 mg/ml or
placebo in a single dose intratympanic injection at a ratio of 2:1. The inclusion criteria require among others
that patients show up for treatment within 48 hours from ASNHL onset and that the average hearing loss is
at least 30 dB in 3 contiguous frequencies. Recruitment for the phase IIb trial with AM-111 is expected to
be completed in early 2012.
About acute sensorineural hearing loss
Acute sensorineural hearing loss (ASNHL) or inner ear hearing loss is the consequence of various insults to
the cochlea. It may result e.g. from overexposure to noise, bacterial or viral infections, inflammation, vascu-
lar compromise, or a variety of other factors. In ASNHL, sensorineural structures of the inner ear – inner and
outer hair cells, neurons – are damaged, as well as other structures such as supporting cells or vascular
tissues. The common observation is a temporary increase in hearing thresholds, i.e. hearing loss. Thanks to
cellular defences and intrinsic repair mechanisms, a certain amount of such hearing loss is frequently re-
covered in the subsequent days and weeks. The remaining hearing loss however is irreversible. ASNHL may
be accompanied by other disorders of the inner ear such as dizziness or tinnitus.
When ASNHL develops into permanent hearing loss, it may have chronically debilitating consequences.
Hearing loss may have serious impacts on professional and personal lives, e.g. through avoidance or with-
drawal from social situations, reduced alertness and increased risk to personal safety, impaired memory and
ability to learn new tasks, or reduced job performance and earning power. To date, there exists no treatment
for ASNHL with proven efficacy.
AM-111 is a cell-permeable peptide that selectively blocks JNK MAPK mediated apoptosis of stress injured
hair cells and neurons in the cochlea. Major cochlear stress incidents that may result in irreversible hearing
loss include exposure to excessive noise, disturbances of the blood supply, viral or bacterial infections, and
exposure to certain ototoxic substances. When administered within a therapeutic time window after the
incident, AM-111 can effectively protect cochlear hair cells and neurons that would otherwise undergo
apoptosis and be lost forever. AM-111’s otoprotective properties have been extensively tested and con-
firmed in various animal models so far, including acute acoustic trauma, acute labyrinthitis, surgery trauma,
aminoglycoside ototoxicity, semicircular canal injury in otitis media and cochlear ischemia. AM-111 has
been granted orphan drug status in both the European Union and the USA for the treatment of acute sen-
sorineural hearing loss. The active substance of AM-111 has been in-licensed by Auris Medical from Swiss
biotechnology company Xigen S.A.
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, email@example.com