Auris Medical Provides Update on Intranasal Betahistine Programs
January 15 2019 - 8:31AM
- Closes acquisition of Orphan Drug Designation for betahistine
for the treatment of obesity associated with Prader-Willi syndrome
(PWS)
- Clinical trial applications for proof-of-concept studies with
intranasal betahistine in acute vertigo and antipsychotic-induced
weight gain submitted for recruitment start in first quarter
2019
Zug, Switzerland, January 15, 2019 - Auris
Medical Holding AG (NASDAQ: EARS), a clinical-stage company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology and CNS disorders, today provided an
update on its intranasal betahistine development programs.
In December 2018, the Company announced the
acquisition of an Orphan Drug Designation for betahistine in the
treatment of obesity associated with Prader-Willi syndrome (PWS).
The transaction is now closed and the transfer of the designation
to Auris Medical has since been recorded by the U.S. Food and Drug
Administration (FDA). PWS is a rare genetic disorder characterized
by progressive obesity, behavioral issues, delayed cognition and
sleep disturbances. In a related transaction, the Company acquired
exclusive rights to in-license two U.S. patents relating to the use
of betahistine for the treatment of depression and
attention-deficit / hyperactivity disorder (ADHD). This transaction
is expected to close in the coming weeks.
In the intranasal betahistine programs for the
treatment of acute vertigo (AM-125) and for the prevention of
antipsychotic-induced weight gain (AM-201), the preparations for
the respective proof-of-concept trials have advanced well. In both
cases, the clinical trial applications have been submitted, and the
Company expects the trials to start recruitment in the first
quarter of 2019. In the AM-125 program, the Phase 2 "TRAVERS" trial
will enroll 138 patients suffering from acute vertigo following
surgical removal of a vestibular schwannoma, a tumor growing behind
the inner ear. In the AM-201 program, a Phase 1b
pharmacokinetic/pharmacodynamics trial will enroll 50 healthy
volunteers who will receive either AM-201 or placebo concomitantly
with olanzapine over four weeks.
About Betahistine
Betahistine is a small molecule structural
analog of histamine, which acts as an agonist at the H1 and as an
antagonist at the H3 histamine receptors. Unlike histamine, it
crosses the blood-brain-barrier. It is known to enhance inner ear
and cerebral blood flow, increase histamine turnover and enhance
histamine release in the brain, increase release of acetylcholine,
dopamine and norepinephrine in the brain and to result in general
brain arousal. Betahistine for oral administration is approved in
about 115 countries, with the US being a notable exception, for the
treatment of vertigo and Meniere's disease. The compound has a very
good safety profile, yet it is also known that its clinical utility
is held back by poor bioavailability. Intranasal administration of
betahistine has been shown to result in 6 to 29 times higher
bioavailability.
About Auris Medical
Auris Medical is a Swiss 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
will move 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 Zug, Switzerland. The shares of Auris Medical
Holding AG 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 or 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 ability to pursue
strategic partnering and non-dilutive funding for its Phase 3
programs, the results of Auris Medical's review of strategic
options and the outcome of any action taken as a result of such
review, the timing and conduct of clinical trials of Auris
Medical's product candidates, 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, 2017, and in Auris
Medical's other filings with the SEC, which are available free of
charge on the Securities Exchange Commission's website at:
www.sec.gov. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those indicated. All
forward-looking statements and all subsequent written and oral
forward-looking statements attributable to Auris Medical or to
persons acting on behalf of Auris Medical are expressly qualified
in their entirety by reference to these risks and uncertainties.
You should not place undue reliance on forward-looking statements.
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.
Investor contact: Joseph Green / Andrew GibsonEdison
Advisors for Auris Medical646-653-7030 / 7719jgreen@edisongroup.com
/ agibson@edisongroup.com
Or
investors@aurismedical.com
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