Auris Medical Completes Enrollment of Phase 1b Proof-Of-Concept Trial of AM-201 in Antipsychotic-Induced Weight Gain
July 03 2019 - 9:00AM
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 completed enrollment in its Phase 1b
proof-of-concept trial of AM-201, the Company’s investigational
drug for the prevention of antipsychotic-induced weight gain and
somnolence.
The Phase 1b trial with AM-201 is being
conducted at one site in Europe. The trial enrolled in total 50
healthy volunteers who received either AM-201 or placebo
concomitantly with the antipsychotic drug olanzapine over four
weeks. The study is testing five different doses of AM-201 under a
dose escalation protocol. The primary efficacy outcome for the
study will be the reduction in weight gain and the secondary
outcome will be the reduction in somnolence.
“Completing enrollment for this proof-of-concept
study is another important step forward with our AM-201 development
program,” commented Thomas Meyer, Auris Medical’s founder, Chairman
and CEO. “Excessive weight gain and somnolence are major side
effects of antipsychotic drugs that frequently have a major impact
on patient well-being and quality of life. We look forward to the
upcoming top-line results from this trial, which are expected in
the coming months.”
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 admin-istration 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 4 to 26 times higher
bioavailability.
About AM-201
Intranasal betahistine is being developed under
project code AM-201 for the prevention of antipsychotic-induced
weight gain and somnolence. Many antipsychotic drugs are known to
block the H1 histamine receptor, which is involved in the control
of appetite and wakefulness, resulting in weight gain and
somnolence as side effects. As an H1 receptor agonist, betahistine
is thought to counteract the antipsychotics’ inhibitory effects; in
addition, betahistine blocks presynaptic H3 histamine
autoreceptors, thus increasing histamine release and in turn
augmenting betahistine’s direct agonistic effects on H1
receptors.
About Auris Medical
Auris Medical is a biopharmaceutical company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology and CNS disorders. The company is
focused on the development of intranasal betahistine for the
treatment of vertigo (AM-125) and for the prevention of
antipsychotic-induced weight gain and somnolence (AM-201). These
projects have gone through two Phase 1 trials and moved 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 with its main operations in Basel, Switzerland.
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 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, 2018, 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 Edison Advisors
for Auris Medical 646-653-7030 jgreen@edisongroup.com
or
investors@aurismedical.com
Auris Medical (NASDAQ:EARS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Auris Medical (NASDAQ:EARS)
Historical Stock Chart
From Sep 2023 to Sep 2024