- Last subject had last treatment visit in Phase 1b trial with
AM-201 in prevention of antipsychotic-induced weight gain and
somnolence; data read-out expected for early May 2020
- Phase 2 trial with AM-125 in treatment of acute peripheral
vertigo progressing towards interim analysis in Q2 2020
Hamilton, Bermuda, March 5, 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 provided
an update on its ongoing clinical trials with intranasal
betahistine.
In the Phase 1b trial with AM-201, intranasal
betahistine for the prevention of antipsychotic-induced weight gain
and somnolence, the last subject just had its last treatment
visit. In total, the trial enrolled 80 healthy volunteers who
received either AM-201 or placebo concomitantly with the
antipsychotic drug olanzapine over four weeks. The study is testing
six 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. The Company expects to report top-line data in early
May 2020, in accordance with previous guidance.
Meanwhile, the Phase 2 trial with AM-125,
intranasal betahistine for the treatment of acute peripheral
vertigo, is progressing towards the interim analysis, which is
expected in the second quarter of 2020. The positive safety data
obtained in the Phase 1b trial with AM-201 allowed for a reduction
in the scope of the dose escalation. In addition to the ongoing
intranasal dose escalation, open label testing of oral betahistine
for reference purposes has commenced. Following the interim
analysis in the second quarter, the Company expects to initiate
Part B of the trial, which plans to enroll 72 patients for
treatment with either a high or a low dose of AM-125 or
placebo.
“We look forward to sharing the results from our
two intranasal betahistine trials during the second quarter of
2020,” commented Thomas Meyer, Auris Medical’s founder, Chairman
and CEO. “Following positive interim data from the AM-201 trial in
October, we will be keen to see the results obtained with the 30 mg
dose, the final and highest level which was tested in 30 additional
subjects. In our AM-125 trial, we expect the interim analysis to
provide important insights into the dose response in acute
peripheral vertigo which will help to inform the selection of doses
for the larger second part of the trial.”
The Company expects to report its 2019
second-half and full year results and to provide a general business
update on March 19, 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, 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 Advisor
for Auris Medical 646-653-7030 jgreen@edisongroup.com
or
investors@aurismedical.com
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