- Acquires Orphan Drug Designation for betahistine for the
treatment of obesity associated with Prader-Willi syndrome
(PWS)
- Signs letter of intent to in-license two US patents covering
use of betahistine for the treatment of depression and
attention-deficit / hyperactivity disorder (ADHD)
Zug, Switzerland, December 6, 2018 - Auris
Medical Holding AG (NASDAQ: EARS), a clinical-stage company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology and mental health supportive care,
today announced a strategic expansion for its intranasal
betahistine development program. In two related transactions, the
Company has acquired an Orphan Drug Designation for betahistine in
the treatment of obesity associated with Prader-Willi syndrome
(PWS) and signed a binding letter of intent to in-license exclusive
rights to two US Patents relating to the use of betahistine for the
treatment of depression and attention-deficit / hyperactivity
disorder (ADHD), respectively.
"We are very excited to address additional
neurological and metabolic disorders with our intranasal
betahistine program," commented Thomas Meyer, Auris Medical's
founder, Chairman and CEO. "Histamine plays a key role in the
regulation of a wide range of behavioral and physiological
functions, including appetite, drinking, sleep, wakefulness,
learning, attention and memory. Betahistine as a structural analog
of histamine has been widely used outside the US for the treatment
of vertigo for decades. It has also shown promising effects in
preventing antipsychotic-induced weight gain, reducing excessive
daytime sleepiness and improving cognitive function. While
betahistine's clinical utility has been limited by poor
bioavailability when administered orally, our intranasal
formulation allows for significantly higher plasma exposure, which
is expected to translate into better therapeutic outcomes and open
up new therapeutic uses."
In Prader-Willi syndrome, a rare genetic
disorder characterized by progressive obesity, behavioral issues,
delayed cognition and sleep disturbances, emerging research
suggests positive effects of H3 histamine receptor inhibition on
cognitive disability and excessive daytime sleepiness. Betahistine
acts as an H3 receptor antagonist and uniquely, also as an agonist
at the H1 histamine receptor, which plays a crucial role in the
regulation of food intake. In animal studies, inhibition or
knock-out of the H1 receptor resulted in increased appetite and the
development of obesity, while food deprivation led to activation of
H1 receptors in the hypothalamus.[1]
Betahistine is expected to offer therapeutic
benefits also in the treatment of ADHD and atypical depression.
ADHD manifests with symptoms, such as hyperactivity, impulsivity
and inattention and is estimated to affect in the US 8.8% of
children between the ages of 4-17 years[2] and 4.4% of the adult
population.[3] In a study with 16 adult ADHD patients, treatment
with oral betahistine up to 200 mg 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).[4]
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.[5] Data from two clinical trials
with oral betahistine provide initial evidence for therapeutic
benefits in depression.[6],[7]
The two transactions are expected to close
before year-end and to have no impact on the Company's development
plans or financial position in the near-term. As previously
announced, the Company prepares for the initiation of two
proof-of-concept studies with intranasal betahistine in the first
quarter of 2019 - one Phase 2 trial with AM-125 in vertigo and one
Phase 1b trial with AM-201 in antipsychotic-induced weight gain.
Based on the outcomes from these trials and discussions with health
authorities about regulatory pathways, the Company plans to
initiate specific developments in the new therapeutic indications
as well.
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 mental health supportive
care. 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
[1] For a review see e.g. Lian et al. (2016), Ameliorating
antipsychotic-induced weight gain by betahistine: Mechanisms and
clinical implications, Pharmacol Res 106: 51-63.
[2] 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.
[3] 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.
[4] 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.
[5] 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.
[6] 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.
[7] 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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