ZUG, Switzerland, June 17, 2016 (GLOBE NEWSWIRE) -- Auris Medical Holding AG (NASDAQ:EARS), a clinical-stage company dedicated
to developing therapeutics that address important unmet medical needs in otolaryngology, today announced it has initiated patient
enrollment in the ASSENT Phase 3 clinical trial of AM-111 in idiopathic sudden sensorineural hearing loss, or ISSNHL, which is also
known as sudden deafness.
"With the enrollment of our first patient in the ASSENT trial, our pivotal program for AM-111 is now fully
initiated," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "For many patients, sudden
deafness is a very frightening experience and may result in chronic hearing loss and tinnitus as well as a significantly reduced
health-related quality of life. The start of ASSENT is yet another important milestone on our way toward the development of AM-111
as the first specific therapeutic for acute inner ear hearing loss."
The ASSENT trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and
tolerability of single-dose intratympanic administration of AM-111. The trial is being conducted in the U.S., Canada and South
Korea and is set to enroll approximately 300 patients who are suffering from severe to profound ISSNHL within 72 hours from onset.
Patients will be randomized to receive AM-111 0.4 mg/mL, 0.8 mg/mL or placebo in a 1:1:1 ratio; oral corticosteroids will be given
as background therapy. The primary efficacy endpoint for the trial is the improvement of pure tone hearing thresholds from baseline
to Day 91.
ASSENT is the second of two pivotal trials in Auris Medical's Phase 3 clinical development program for AM-111.
The first trial, HEALOS, which is being conducted in several European and Asian countries, was initiated in November 2015 and is
enrolling approximately 255 patients. In the Phase 2 clinical trial program, patients with severe to profound hearing loss who were
treated with AM-111 0.4 mg/mL showed a statistically significant improvement in hearing threshold, speech discrimination and a
higher rate of complete tinnitus remission compared with placebo.
About Acute Inner Ear Hearing Loss
Acute injury to the cochlea, e.g. from overexposure to noise, bacterial or viral infections, inflammation, or
vascular compromise may result in damage to inner ear hair cells and neurons and acute hearing loss. Thanks to cellular defenses
and intrinsic repair mechanisms, a certain amount of hearing loss can be recovered in the subsequent days and weeks following the
insult. However, the remaining hearing loss is irreversible. Acute inner ear hearing loss may be accompanied by other disorders of
the inner ear such as dizziness or tinnitus, and if it develops into permanent hearing loss, it may have chronically debilitating
consequences. Hearing loss may have a serious impact on professional and personal lives, e.g. through avoidance or withdrawal 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 acute inner ear hearing loss with proven
efficacy.
About AM-111
AM-111 contains the synthetic peptide D-JNKI-1 (D-stereoisomer of c-Jun N-terminal Kinase Inhibitor 1), a
cell-penetrating inhibitor of the JNK stress kinase. JNK is activated following various types of cochlear insults (stress) that
cause acute inner ear hearing loss and plays a key role in the apoptosis of cochlear hair cells and neurons as well as in
inflammatory responses. By blocking JNK, AM-111 protects stress-injured cochlear cells and helps to prevent or reduce chronic
hearing loss. AM-111's otoprotective effects have been demonstrated in various animal models of cochlear stress, including acute
acoustic trauma, acute labyrinthitis (inflammation), drug ototoxicity (aminoglycosides), bacterial infection, cochlear ischemia and
cochlear implantation trauma. Clinically, AM-111 has been evaluated in two completed trials and is currently being tested in two
pivotal Phase 3 trials. It is administered intratympanically in one single dose. AM-111 has orphan drug designation from both the
U.S. Food and Drug Administration and the European Medicines Agency.
About Auris Medical
Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important
unmet medical needs in otolaryngology. The Company is currently focusing on the development of treatments for acute inner ear
tinnitus (Keyzilen; AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic administration with biocompatible
gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in
2003 and is headquartered in Zug, Switzerland. The shares of the parent company Auris Medical Holding AG trade on the NASDAQ Global
Market under the symbol "EARS."
Forward-looking Statements
This press release may contain statements that constitute "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are
statements other than historical fact and may include statements that address future operating, financial or business performance
or Auris Medical's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as
"may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential,"
"outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current
expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business
decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not
limited to, the timing and conduct of clinical trials of Auris Medical's product candidates, the clinical utility of Auris
Medical's product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical's intellectual property
position and Auris Medical's financial position, including the impact of any future acquisitions, dispositions, partnerships,
license transactions or changes to Auris Medical's capital structure, including future securities offerings. These risks and
uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Auris Medical's Annual
Report on Form 20-F and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the
date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future
developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their
entirety by this cautionary statement.
Contact: Cindy McGee, Head of Investor Relations and Corporate Communications, +41 61 201 1350, investors@aurismedical.com
HUG#2021392
