Auris Medical Provides Update on Tinnitus Drug Development Strategy
April 25 2019 - 9:00AM
Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology and central nervous system disorders,
today provided an update on its tinnitus drug development strategy.
The Company intends to discuss and validate the protocol for a
pivotal clinical trial with its late-stage investigational drug
Keyzilen® (AM-101) with the U.S. Food and Drug Administration (FDA)
and European Medicines Agency (EMA) and to take the program forward
through partnering or other types of non-dilutive funding.
The Company has completed the design of a new
Phase 2/3 trial for its late-stage Keyzilen® program. The trial
shall, in two stages, reaffirm the compound’s efficacy in the
treatment of acute tinnitus following traumatic cochlear injury and
provide confirmatory efficacy data to support a filing for
marketing authorization. It will incorporate learnings from the
four late-stage trials, TACTT2, TACTT3, AMPACT1 and AMPACT2,
notably with regard to the collection of patient reported outcomes
and certain elements of study conduct. In addition, it will explore
the use of a novel method for objective tinnitus diagnosis and
measurement. The Company intends to discuss and validate the Phase
2/3 trial design with the FDA and EMA.
The Company aims to implement the further
development of Keyzilen® as well as its early-stage tinnitus
programs with non-dilutive funding. Funding options which are under
consideration include: strategic partnering, special purpose
vehicle financing, grant funding or a combination thereof.
“From the analysis of the large amounts of trial
data and based on feedback from investigators as well as patients,
we have gained a clear understanding of how to improve tinnitus
measurement and trial conduct in a new pivotal study with
Keyzilen®,” stated Thomas Meyer, Auris Medical’s founder, Chairman
and CEO. “In addition, we expect the use of novel objective
tinnitus diagnostics and measures to enhance patient selection and
support patient reported outcomes. Given the strong unmet medical
need among tinnitus sufferers worldwide, the positive data obtained
with Keyzilen® from non-clinical studies as well as two Phase 2
trials and the two AMPACT trials, we remain committed to bringing
this first-in-class therapy to patients. We look forward to our
discussions with the regulatory agencies and to providing further
updates on this promising program.”
About 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 inflammation. Tinnitus may be transitory; however, it
may also become permanent. Tinnitus of less than three months of
duration is considered acute, while older tinnitus is considered
chronic. Inner ear tinnitus often has a serious impact on the
ability to sleep, relax, or concentrate, and it may lead to
tiredness, irritation, nervousness, despair, frustration, or even
depression. As of today, neither a universal standard of care for
acute inner ear tinnitus, nor a truly proven and effective
treatment method is available.
About Keyzilen® / AM-101
Keyzilen® is a small molecule
N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a
biocompatible gel and delivered by intratympanic administration.
Keyzilen® is in development for treatment of acute tinnitus
following traumatic cochlear injury. Emerging evidence suggests
that NMDA receptors in the cochlea play a major role in the
occurrence of tinnitus following acute traumatic injury to the
inner ear. Persistent overexpression of NMDA receptors may lead to
pathologic excitation of auditory nerve fibers, which in the brain
is perceived as tinnitus. The development of Keyzilen® is based on
research conducted at the INSERM Institute for Neurosciences, and
patents have been granted in more than 40 countries worldwide so
far.
About Auris Medical
Auris Medical is a biopharmaceutical company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology and mental health supportive care. The
company is focused on the development of intranasal betahistine for
the treatment of vertigo (AM-125) and for the prevention of
antipsychotic-induced weight gain and somnolence (AM-201). These
projects have gone through two Phase 1 trials and will move into
proof-of-concept studies in 2019. In addition Auris Medical has two
Phase 3 programs under development: Sonsuvi® (AM-111) for acute
inner ear hearing loss and Keyzilen® (AM-101) for acute inner ear
tinnitus. The Company was founded in 2003 and is headquartered in
Hamilton, Bermuda with its main operations in Basel, Switzerland.
The shares of Auris Medical Holding Ltd. trade on the NASDAQ
Capital 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 facts 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”, or the negative of these terms or 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, Auris Medical’s need
for and ability to raise substantial additional funding to continue
the development of its product candidates, the ability to pursue
strategic partnering and non-dilutive funding for its Phase 3
programs Keyzilen® and Sonsuvi®, the results of Auris Medical’s
review of strategic options and the outcome of any action taken as
a result of such review, 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 for the year ended December 31, 2018, and in Auris
Medical's other filings with the SEC, which are available free of
charge on the Securities Exchange Commission's website at:
www.sec.gov. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those indicated. All
forward-looking statements and all subsequent written and oral
forward-looking statements attributable to Auris Medical or to
persons acting on behalf of Auris Medical are expressly qualified
in their entirety by reference to these risks and uncertainties.
You should not place undue reliance on forward-looking statements.
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.
Investor contact: Joseph Green Edison Advisors
for Auris Medical 646-653-7030 / 7719
jgreen@edisongroup.com
or
investors@aurismedical.com
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