Auris Medical Announces Initiation of Part B of TRAVERS Phase 2 Study with AM-125 in Vertigo
October 13 2020 - 9:00AM
Hamilton, Bermuda, October 13, 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 that the first patient has been randomized in Part
B of its “TRAVERS” Phase 2 trial of AM-125 (intranasal betahistine)
in acute vertigo. This follows the positive read-out from the
interim analysis on Part A of the study in early September 2020,
the completion of enrollment into the oral treatment group, and the
receipt of regulatory clearance for Part B in the first three of
the participating study countries.
In Part B of the TRAVERS trial, the Company will
enroll 72 patients who suffer from acute vertigo following
neurosurgery. They will be 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.
As the Company remained blinded to treatment allocation during the
interim analysis, the corresponding data from Part A will be pooled
with those from Part B.
“In Part A of the TRAVERS trial, we demonstrated
good safety and tolerability of AM-125 and observed a compelling
dose response effect with active treated patients, showing up to
1.9 to 2.4 times better performance in key balance tests,”
commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO.
“With Part B, we aim to confirm these positive outcomes with the
two highest doses in a larger patient sample and, based on those
results, advance the program into Phase 3 development. For patients
suffering from vertigo, regaining balance as quickly as possible is
of utmost importance. 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’.”
The Company expects to complete enrollment into
Part B of the TRAVERS trial by the end of the first quarter 2021,
provided that the Covid-19 pandemic does not cause further
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
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 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, in Phase 2) and for the prevention of
antipsychotic-induced weight gain and somnolence (AM-201, post
Phase 1b). With AM-301, the Company is developing a nasal spray for
protection against airborne pathogens 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, 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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