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 the successful closing of the purchase of two US
patents related to the use of betahistine for the treatment of
depression and attention-deficit / hyperactivity disorder (ADHD).
The Company acquired full ownership of the US patents 8,119,668 and
8,242,148, “Treatment methods employing histamine H3 receptor
antagonists, including betahistine,” with key claims directed
towards the treatment of depression and ADHD, respectively.
“We are very pleased to add two more patents to
our growing portfolio of betahistine related intellectual property,
which now comprises five issued US patents,” commented Thomas
Meyer, Auris Medical’s founder, Chairman and CEO. “ADHD and
atypical depression are frequent mental disorders that can have a
substantial impact on an individual’s day-to-day function and
quality of life. Based on betahistine’s mechanism of action and
supportive preliminary data, we expect it to offer therapeutic
benefits also in the treatment of these two conditions. The
magnitude of such benefits will potentially be further augmented by
our intranasal delivery approach, which provides significantly
higher bioavailability compared to the currently established oral
delivery approach.”
In the US, ADHD is estimated to affect 8.8% of
children between the ages of 4-17 years1 and 4.4% of the adult
population.2 The disorder manifests with symptoms such as
hyperactivity, impulsivity and inattention. As demonstrated by the
two inventors in a study with 16 adult ADHD patients, treatment
with a high dose of oral betahistine resulted in a statistically
significant improvement in surrogate markers for cognitive
outcomes, attentional sensitivity in the Continuous Performance
Task and inhibition in the Go/No-Go task, compared to placebo
(p=0.02 and 0.004).3
Atypical depression is a subtype of major
depression. It is characterized by mood reactivity, fatigue,
excessive somnolence, increased appetite or weight gain and
cognitive deficits. Estimates in both community and clinical
settings suggest that 15.7% to 36.6% of patients with depression
present with atypical features.4 Data from two clinical
trials with oral betahistine provide initial evidence for
therapeutic benefits in depression.5,6
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 Auris Medical
Auris Medical is a biopharmaceutical company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology and mental health supportive care. 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 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
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
1 Visser et al. (2014), Trends in the parent-report of health
care provider diagnosed and medicated
attention-deficit/hyperactivity disorder: United States, 2003-2011.
J Am Acad Child Adolesc Psychiatry 53(1):34-46.
2 Kessler et al. (2006), The prevalence and correlates of adult
ADHD in the United States: results from the National Comorbidity
Survey Replication. Am J Psychiatry 163(4):716-723.
3 Moorthy et al. (2015), Safety, tolerability and
pharmacokinetics of 2-pyridylacetic acid, a major metabolite of
betahistine, in a phase 1 dose escalation study in subjects with
ADHD. Biopharm. Drug Dispos. 36:429-439.
4 For a review see e.g. Cristancho et al. (2011), Atypical
depression in the 21st century: diagnostic and treatment issues.
Psychiatric Times 28[1]:42-47.
5 Morozova et al. (2015), Effects and safety profile of
betahistine in patients in the Russian contingent of OSVaLD, an
open-label observational study in vestibular vertigo. Int J Gen
Med. 8:47-53.
6 Barak et al. (2016), A randomized, double-blind,
placebo-controlled pilot study of betahistine to counteract
olanzapine-associated weight gain. J Clin Psychopharmacol.
36(3):253-6.
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