Auris Medical Completes Enrollment of Phase 3 HEALOS Trial of AM-111 for the Treatment of Sudden Deafness
July 05 2017 - 8:01AM
- Top-line results from the HEALOS trial are expected in the fall
of 2017
Zug, Switzerland, July 5, 2017 - Auris Medical
Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to
developing therapeutics that address important unmet medical needs
in otolaryngology, today announced that it has completed patient
enrollment in the Phase 3 HEALOS clinical trial of AM-111 in
idiopathic sudden sensorineural hearing loss (ISSNHL), also known
as sudden deafness. Top-line results from the HEALOS trial are
expected in the fall of 2017.
"We are very pleased that our first Phase 3
clinical trial of AM-111 is now fully enrolled with 256 patients,"
commented Thomas Meyer, Auris Medical's founder, Chairman and Chief
Executive Officer. "AM-111 could become the first specific
therapeutic for patients with acute inner ear hearing loss, a
condition that can severely impact day-to-day functioning. We are
proud to have pioneered the development of AM-111 and look forward
to results from the HEALOS trial later this year."
The HEALOS 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 several European and Asian
countries and has enrolled patients who are suffering from severe
to profound ISSNHL within 72 hours from onset. Patients were
randomized to receive AM-111 0.4 mg/mL, 0.8 mg/mL or placebo in a
1:1:1 ratio. The primary efficacy endpoint for the trial is the
improvement of pure tone hearing thresholds from baseline to Day
28.
HEALOS is the first of two pivotal trials in Auris
Medical's Phase 3 clinical development program for AM-111. The
second Phase 3 trial, ASSENT, is set to enroll approximately 300
patients. Auris Medical expects to announce top-line results from
the ASSENT trial in the second half of 2018.
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 brimapitide, or 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. The otoprotective effects of AM-111 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 delivered by
intratympanic administration in one single dose. AM-111 has orphan
drug designation from both the U.S. Food and Drug Administration
(FDA) and the European Medicines Agency and fast track designation
from the FDA.
About Auris Medical
Auris Medical is a Swiss biopharmaceutical company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology. The Company is focused on the Phase 3
development of treatments for acute inner ear hearing loss (AM-111)
and for acute inner ear tinnitus (Keyzilen®; AM-101) by way of
intratympanic administration with biocompatible gel formulations.
In addition, Auris Medical is developing intranasal betahistine for
Meniere's disease and vestibular vertigo (AM-125) as well as
early-stage research and development projects. The Company was
founded in 2003 and is headquartered in Zug, Switzerland. The
shares of 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, including the likelihood that the
TACTT3 clinical trial with Keyzilen® will not meet its endpoints,
the acceptability of the data from AMPACT1 and AMPACT2 in support
of a potential new drug application to the FDA and other
regulators, 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; the use of proceeds from Auris Medical's
recent equity offering and the ability of Auris Medical to finance
its operations in the future. 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.
Company contact: Cindy McGee, Head of Investor
Relations and Corporate Communications, +41 61 201 1350,
investors@aurismedical.com
Media contact: David Schull, Russo Partners,
1-858-717-2310,david.schull@russopartnersllc.com
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