- Trial outcomes provide further evidence for safety of
Keyzilen® in chronic intermittent use
- Exploratory efficacy results suggest potential benefits of
repeating treatment cycles
Zug, Switzerland, May 9, 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 key results from AMPACT1
(AM-101 in the Post-Acute Treatment of
Peripheral Tinnitus 1), the open-label extension
study of the Phase 3 TACTT2 clinical trial. The study provides
additional confirmation on the long-term safety of Keyzilen® and
suggests the potential for further therapeutic benefits from
repeated treatment.
"We are very pleased that the AMPACT1 trial
showed good tolerance and safety for Keyzilen® with
chronic intermittent use and thus confirms the positive results
from the AMPACT2 trial," commented Thomas Meyer, Auris Medical's
founder, Chairman and Chief Executive Officer. "In addition, we are
glad to see from exploratory efficacy data that the TACTT2 patients
who continued into AMPACT1 on average were able to reduce the
burden and severity of their tinnitus with repeated treatment."
AMPACT1 is the second of two open-label extension
studies with Keyzilen® that were conducted in response to a request
from the US Food and Drug Administration (FDA) for safety data from
chronic intermittent use of Keyzilen® for up to 12 months.
Participants who completed the TACTT2 trial were offered the option
to roll over into AMPACT1, while still blinded to the treatment
allocation. Patients were given the choice to receive up to three
treatment cycles with each cycle comprising three intratympanic
administrations of Keyzilen®, followed by a treatment-free
observation period of 12 weeks.
TACTT2 and AMPACT1 were primarily conducted in
North America. Patients enrolled in TACTT2 within three months from
tinnitus onset, i.e. during the acute stage. Of the 316 patients
who completed the TACTT2 trial, 257 patients rolled over into
AMPACT1 and provided safety data; 228 of these patients provided
exploratory efficacy data. At the time of enrollment into AMPACT1,
all patients were in the post-acute stage.
The primary safety endpoint of AMPACT1 was the
incidence of clinically relevant hearing deterioration five weeks
after the start of a treatment cycle. In line with the results from
previous trials with Keyzilen®, such incidence was low (6%), with
no signs of treatment-related effects. Over the course of AMPACT1,
the hearing threshold at the average of 4, 6 and 8 kHz showed only
little change. The vast majority of adverse events that were
considered related to the study drug or treatment procedure were
rated as either mild or moderate in intensity. Three patients
experienced a total of four non-fatal, serious adverse events, none
of which was considered related to the study drug. Confirming
previous data, about 93% of tympanic membranes were already closed
at the time of the first follow-up visit.
Exploratory efficacy analyses of AMPACT1 show
improvements in the Tinnitus Functional Index (TFI) as well as
other tinnitus metrics. The TFI decreased on average by 8.2 points
(95% confidence interval 6.2 to 10.1; baseline of 42.7 points) to
the last follow-up visit. The more treatment cycles the patients
received, the larger the reduction in the TFI was; the difference
between three cycles and one cycle reached statistical
significance. Similar results were achieved on subjective tinnitus
loudness and tinnitus annoyance. In addition, 41% of AMPACT1
participants achieved a reduction in their tinnitus severity
(extreme-severe-moderate-mild-none) by at least one grade and 28%
reported that their tinnitus severity had improved "much" or "very
much" compared to baseline.
Auris Medical expects to announce results from
TACTT3, the European placebo-controlled sister trial to TACTT2, in
early 2018. The trial has been extended to recruit an additional 60
patients in each of the acute and post-acute strata (i.e. up to
three months and between three and six months from onset), and
enrollment is ongoing.
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 otolaryngology. 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 pursuing 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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