Auris Medical on Track to Resume Enrollment of Keyzilen™ Tinnitus Program Following Regulatory Feedback
December 06 2016 - 6:00AM
Auris Medical Holding AG (NASDAQ:EARS), a clinical-stage company
dedicated to developing therapeutics that address important unmet
medical needs in otolaryngology, today confirmed that the TACTT3
Phase 3 trial with KeyzilenTM (AM-101) will resume enrollment
in early 2017 as per previous guidance. This announcement follows
receipt of key approvals from regulatory agencies and ethics
committees in Europe on the recently submitted TACTT3 protocol
amendment.
“We believe that the protocol amendment we are
implementing improves TACTT3’s probability of success, and we look
forward to top-line results from this trial in early 2018,”
commented Thomas Meyer, Auris Medical’s founder, Chairman and Chief
Executive Officer. “With Keyzilen’s strong safety profile and
positive data from several trials, we are working to realize the
potential of what could become the first pharmacological treatment
for patients who suffer from acute tinnitus of the inner ear.”
As previously announced, the TACTT3 protocol was
amended based on analysis of the TACTT2 Phase 3 trial outcomes. The
amended protocol elevates the Tinnitus Functional Index score from
a key secondary endpoint to an alternate primary efficacy endpoint,
includes certain patient subgroups in confirmatory statistical
testing and increases the trial size with the enrollment of an
additional 120 patients.
As part of the Company’s continued dialogue with
the U.S. Food and Drug Administration (FDA), Auris Medical recently
had two meetings related to the KeyzilenTM program. Through a Type
C Meeting, the FDA confirmed that, as per standard practice, two
positive confirmatory trials would be required to submit a New Drug
Application (NDA); the Agency did not provide feedback on the
TACTT3 protocol amendment because the trial is being conducted in
Europe and is not under the Investigational New Drug Application.
In a separate meeting with the FDA, alignment was achieved on key
items of the KeyzilenTM Chemistry, Manufacturing, and Controls
section for a future NDA.
About Acute Inner Ear 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 KeyzilenTM
(AM-101)
KeyzilenTM is a small molecule
N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a
biocompatible gel for intratympanic injection. Emerging evidence
suggests that NMDA receptors in the cochlea play a major role in
the occurrence of tinnitus following acute injury to the inner ear,
e.g. from exposure to excessive noise, infections, disturbances in
inner ear blood supply, or the administration of certain ototoxic
drugs. 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 KeyzilenTM 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 Swiss biopharmaceutical
company dedicated to developing therapeutics that address important
unmet medical needs in otolaryngology. The Company is currently
focusing on the Phase 3 development of treatments for acute inner
ear tinnitus (KeyzilenTM; 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,”
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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, including the likelihood that the
TACTT3 trial may not meet its endpoints, 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
Media contact: David Schull, Russo Partners, 1-858-717-2310, david.schull@russopartnersllc.com
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