Auris Medical Announces Positive Interim Results from AM-201 Phase 1b Study in Antipsychotic-Induced Weight Gain
October 11 2019 - 8:30AM
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 positive interim results from its Phase 1b trial
with AM-201 in antipsychotic-induced weight gain and somnolence.
The study demonstrated good safety and tolerability of AM-201 over
the four-week treatment period and revealed relevant reductions in
olanzapine-induced weight gain and daytime sleepiness. In female
study participants, who overall showed more pronounced changes than
male participants, a reduction in weight gain of 1.1 kg against
placebo was observed at the highest tested dose of 20 mg three
times per day (probability of effectiveness = 90%). The study will
now proceed to the next higher and final dose level of 30 mg to be
tested on 30 healthy volunteers.
“We are very pleased to see the good safety and
tolerability of intranasal betahistine confirmed over an extended
period of time and are encouraged by the first efficacy signals
observed in the indication of antipsychotic-induced weight gain and
somnolence prevention“, commented Thomas Meyer, Auris Medical’s
founder, Chairman and CEO. “We look forward to confirming and
expanding these results in a larger dose cohort in the second leg
of the study, for which we anticipate a data read-out towards the
end of the first quarter of 2020.”
“Weight gain and somnolence are major side
effects of olanzapine and other antipsychotic medications and often
inflict a major burden on the health and quality of life of
patients”, stated Nir Barak, MD, member of Auris Medical’s
Scientific Advisory Board. “Olanzapine is still considered one of
the most efficacious antipsychotic drugs, yet its clinical use is
often restricted due to the risk of substantial weight gain and
metabolic adverse effects such as impaired glucose tolerance, new
onset diabetes, hyperlipidemia or cardiovascular disease. A major
cause of the weight gain associated with the use of olanzapine and
many other antipsychotic drugs is the inhibition of the histamine
H1 receptor, which betahistine seeks to counteract.”
The Phase 1b trial with AM-201 in
antipsychotic-induced weight gain and somnolence is being conducted
at a single trial site in Europe and has enrolled 50 healthy
volunteers to date. Participants received either AM-201 (1, 2.5, 5,
10 or 20 mg) or placebo three times a day in parallel with oral
olanzapine (10 mg) once a day for four weeks. The primary efficacy
outcome for the trial is the reduction in olanzapine-induced weight
gain; the secondary efficacy outcome is the reduction in
olanzapine-induced daytime sleepiness.
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 5 to 29 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 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.”
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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
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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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