- 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."
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, Auris Medical's need for and ability to raise 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 endpoints , 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.
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
