Auris Medical Reaches Midpoint for Enrollment in Part B of AM-125 Phase 2 TRAVERS Trial in Acute Peripheral Vertigo
14 Maggio 2021 - 2:30PM
Hamilton, Bermuda, May 14, 2021 – Auris Medical
Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to
developing therapeutics that address important unmet medical needs
in neurotology, rhinology and allergy and CNS disorders, today
announced that it has reached the midpoint for enrollment in Part B
of its Phase 2 proof-of-concept trial of AM-125 (intranasal
betahistine) in the treatment of acute peripheral vertigo.
In Part B of the TRAVERS trial, the Company will
enroll 72 patients who suffer from acute peripheral vertigo
following neurosurgery. They are randomized to receive either 10 or
20 mg of intranasal betahistine or a placebo three times daily for
four weeks. The improvement in the “Standing on Foam” test from
baseline to Day 14 will be the primary efficacy endpoint; the
improvement in the “Tandem Romberg” test to Day 42 (i.e. two weeks
after completion of treatment) will be the key secondary efficacy
endpoint. The two tests measure how long patients are able to
maintain balance on a foam mat or with the two feet aligned one
after the other, respectively, while they have their eyes closed.
An interim analysis based on Part A of the TRAVERS trial had shown
a positive dose-response relationship with active-treated patients
performing up to 1.9 to 2.4 times better in the two key balance
tests.
“We are very pleased to have reached this
important interim milestone in the TRAVERS trial and to see
recruitment rates recovering from the slow-down imposed by the
second Covid-19 wave in recent months,” commented Thomas Meyer,
Auris Medical’s founder, Chairman and CEO. “We look forward to
completing the TRAVERS trial later in 2021 and to advancing the
AM-125 program further. Unlike other vertigo drugs that suppress
the vestibular function to treat just short-term symptoms such as
nausea, AM-125 acts as a vestibular stimulant to enhance and
accelerate vestibular compensation and help patients to ‘get back
on their feet’ more quickly. There is a strong medical need for a
novel drug in this area, with e.g. 35.4% of the US population aged
40 years and older suffering from vestibular dysfunction (i.e.
failing the ‘Standing on Foam’ test).”
The Company expects to complete enrollment into
Part B of the TRAVERS trial by the end of the third quarter 2021,
provided that the Covid-19 pandemic does not cause renewed
restrictions on patient enrollment.
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 oral
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 peripheral 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 Auris Medical
Auris Medical is a clinical-stage company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology, rhinology and allergy and CNS
disorders. The Company is focused on the development of intranasal
betahistine for the treatment of vertigo (AM-125, in Phase 2) and
for the prevention of antipsychotic-induced weight gain and
somnolence (AM-201, post Phase 1b). Through its affiliate Altamira
Medica, the Company is developing BentrioTM (AM-301), a nasal spray
for protection against airborne viruses and allergens. 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, the approval and
timing of commercialization of AM-301, 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, 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, 2020, 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:
investors@aurismedical.com
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