Auris Medical Completes Patient Recruitment for Phase 3 TACTT3 Trial of Keyzilen® in Acute and Post-Acute Tinnitus
September 22 2017 - 8:01AM
- Trial now includes more than 730 patients under previously
announced amended protocol
- Top-line results from TACTT3 expected in first quarter
2018
Zug, Switzerland, September 22, 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 the recruitment of patients for the Phase 3 TACTT3
clinical trial of Keyzilen® in acute and post-acute inner
ear tinnitus. The trial enrolled more than 365 patients during both
the acute tinnitus stage (Stratum A) and the post-acute tinnitus
stage (Stratum B). Top-line results from the TACTT3 trial are
expected in the first quarter of 2018.
"We are pleased to complete the recruitment of
patients for TACTT3, our pivotal trial with Keyzilen® in Europe,"
commented Thomas Meyer, Auris Medical's founder, Chairman and Chief
Executive Officer. "Keyzilen® has the potential to become the first
specific pharmacological treatment for patients with inner ear
tinnitus and we look forward to announcing top-line results from
TACTT3 early next year."
TACTT3 is a randomized, double-blind,
placebo-controlled Phase 3 trial in inner ear tinnitus following
traumatic cochlear injury or otitis media. As previously announced,
the TACTT3 protocol was amended based on analysis of the TACTT2
Phase 3 trial outcomes. The primary efficacy endpoints for the
trial include either the improvement of tinnitus loudness or
improvement in Tinnitus Functional Index score. In addition, the
amended protocol includes certain patient subgroups in confirmatory
statistical testing and the trial size was increased.
About Acute Inner Ear Tinnitus
Tinnitus is the perception of sound without
external acoustic stimulation. Tinnitus of the inner ear may be
caused by various injuries to the cochlea, the organ of hearing,
such as overexposure to noise. Tinnitus that has been present for
less than three months is considered acute, while tinnitus that has
been present for over three months is considered chronic. Tinnitus
of the inner ear often has a serious impact on ability to sleep,
relax or concentrate, which may lead to tiredness, irritation,
anxiety or depression. There is no universal standard of care for
tinnitus of the inner ear and efficacy of a pharmacological
treatment for tinnitus of the inner ear has not yet been
conclusively demonstrated.
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 injection. Keyzilen® is in development
for treatment of acute tinnitus of the inner ear. 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 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 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 other vestibular disorders (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."
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constitute "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
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substantial additional funding to continue the development of its
product candidates, 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
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and Auris Medical does not undertake any obligation to update them
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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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