Auris Medical Receives FDA and EMA Guidance for Keyzilen® Late-Stage Clinical Development Program
13 Setembro 2019 - 10:00AM
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 announced that it has obtained advice on the development plan
and regulatory pathway for its investigational tinnitus treatment
Keyzilen® (AM-101) from the U.S. Food and Drug Administration
(“FDA”) and from the European Medicines Agency (“EMA”). The Company
had reached out to the two agencies in order to discuss and
validate the design of a new Phase 2/3 trial for the Keyzilen®
program. The advice was provided in the context of a Type C meeting
and a Scientific Advice procedure, respectively.
In their feedback, both the FDA and EMA
supported the use of the Tinnitus Functional Index (TFI)
questionnaire as the primary efficacy outcome measure. The TFI
captures the impact of tinnitus on the patient’s day-to-day
functioning. Furthermore, the two agencies agreed on a less
frequent collection of patient-reported tinnitus loudness than in
the previous Keyzilen® trials, where daily ratings had turned out
to be problematic. The FDA considers the improvement in tinnitus
loudness as a co-primary efficacy endpoint, whereas the EMA
endorsed it as a secondary efficacy endpoint. In addition, the two
agencies endorsed the planned sample size for the trial and
provided important guidance on the regulatory path forward.
“We very much appreciate the objective feedback
and guidance from the FDA and EMA on our Keyzilen® program”,
commented Thomas Meyer, Auris Medical’s founder, chairman and CEO.
“We are very pleased to be aligned with the FDA and EMA on the key
design aspects for the planned Phase 2/3 trial and look forward to
working with the agencies as we continue to develop Keyzilen® as a
potential first-in-class treatment for acute inner ear
tinnitus.”
The planned Phase 2/3 trial shall, in two
stages, reaffirm and confirm the efficacy of Keyzilen® in the
treatment of acute tinnitus following traumatic cochlear injury. It
will incorporate learnings from the previous 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, the trial will explore the use of a
novel method for objective tinnitus diagnosis and measurement. The
Company aims to further develop Keyzilen® with the aid of
non-dilutive funding. The funding options which are currently under
consideration include: strategic partnering, special purpose
vehicle financing, grant funding or a combination thereof.
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 central nervous system disorders.
The company is focused on the development of intranasal betahistine
for the treatment of vertigo (AM-125) and for the treatment of
antipsychotic-induced weight gain and somnolence (AM-201). These
projects have gone through two Phase 1 trials and entered 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. 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 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 and that
such trials will not meet their 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 for the year ended December 31, 2018 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.
Investor contact:
Joseph Green Edison Advisors for Auris Medical
646-653-7030 jgreen@edisongroup.com
Or
investors@aurismedical.com
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