Auris Medical Announces Positive Top-Line Data from AM-201 Phase 1b Study in Antipsychotic-Induced Weight Gain and Provides U...
May 26 2020 - 8:30AM
- Administration of intranasal betahistine 30 mg shows
statistically significant reduction in olanzapine-induced weight
gain
- Treatment well tolerated and safe with no adverse effects
- Enrollment into Phase 2 TRAVERS trial with AM-125 resumed
following break due to COVID-19 pandemic
Hamilton, Bermuda, May 26, 2020 – 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 top-line data from its Phase 1b trial with
AM-201 in antipsychotic-induced weight gain and provided an update
on the enrollment into its Phase 2 trial with AM-125 in
vertigo.
The Phase 1b trial demonstrated good safety and
tolerability of ascending doses of AM-201 as well as a
dose-dependent reduction in weight gain in healthy volunteers
treated with oral olanzapine (10 mg) for four weeks. At the highest
AM-201 dose of 30 mg administered three times daily, the mean
weight gain from baseline to the end of the treatment period was
2.8 kg compared against 3.7 kg in control subjects; the primary
efficacy endpoint of mean reduction in weight gain was 0.9 kg and
statistically significant (p<0.02; n=81 with pre-specified
Bayesian augmented controls). As expected, intranasal delivery of
betahistine allowed for substantially higher concentrations in
blood plasma compared with levels previously reported for oral
betahistine.
“We are very pleased with the positive safety,
efficacy and pharmacokinetic outcomes achieved with intranasal
betahistine in our first clinical trial for the prevention of
antipsychotic-induced weight gain“, commented Thomas Meyer, Auris
Medical’s founder, Chairman and CEO. “Weight gain and related
metabolic or cardiovascular problems are major side effects of
olanzapine and other antipsychotic medications, which often results
in a major burden on the health and quality of life of patients. We
are delighted to see the positive efficacy signals with AM-201 as
well as the excellent tolerability of the nasal spray application
in the Phase 1b trial.” Following completion of the data analysis,
the Company intends to prepare a Phase 2 clinical trial and to
disclose detailed results from the study in a scientific
journal.
In addition, the Company announced that the
Phase 2 TRAVERS trial with AM-125 in acute peripheral vertigo has
resumed enrollment. The COVID-19 outbreak had led to a standstill
of recruitment towards the end of March 2020 as trial sites
postponed elective surgeries, including those generating the type
of acute vertigo required for study participation, and temporarily
reduced or suspended clinical research activities. As the COVID-19
outbreak has started to subside in several European countries, a
small number of trial sites have resumed recruitment in the past
few weeks. Barring the reintroduction of COVID-19 related
restrictions, the Company expects further sites to reopen in the
coming weeks and the interim analysis following Part A of the trial
to be completed in the third quarter of 2020.
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. 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-125
Intranasal betahistine is being developed under
project code AM-125 for the treatment of acute vertigo. Betahistine
has been shown to increase cochlear, vestibular and cerebral blood
flow, facilitate vestibular compensation and inhibit neuronal
firing in the vestibular nuclei. 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.
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, 2019, 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 Advisor
for Auris Medical 646-653-7030 jgreen@edisongroup.com
or
investors@aurismedical.com
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