Auris Medical Announces Completion of Enrollment into First Part of TRAVERS Phase 2 Study with AM-125 in Vertigo
July 29 2020 - 8:30AM
- Dose escalation completed as last patient enrolled into Part A
of TRAVERS study
- Interim results to be announced in Q3 of 2020
Hamilton, Bermuda, July 29, 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 the completion of patient enrollment into Part A of its
Phase 2 “TRAVERS” trial with intranasal betahistine in vertigo
(AM-125). The Company expects to release interim results from
TRAVERS and commence Part B of the trial in the coming weeks.
Thomas Meyer, Auris Medical’s founder, Chairman
and CEO commented, “Thanks to a quicker than expected recovery of
study activities following the COVID-19 outbreak, we are very
pleased to announce the completion of enrollment into Part A of
TRAVERS. We look forward to analyzing the interim results and
anticipate further improvement in recruitment rates as we will
begin Part B of TRAVERS.”
In Part A of the TRAVERS trial, three ascending
doses of AM-125 or placebo, administered three times daily over a
total of four weeks, will be tested in a total of 30 patients. The
primary endpoint will be the improvement of vestibular function
from baseline to Day 14. This is assessed by measuring for how long
patients are able to maintain their balance with eyes closed – once
while standing on foam, and once while doing the tandem Romberg
test, which requires the two feet to be aligned one after the
other. The results from the interim analysis will inform the
selection of two doses for further testing against placebo in an
estimated 72 patients in Part B of the trial. While the interim
analysis will be carried out and prior to starting Part B, open
label testing of oral betahistine for reference purposes will be
completed (n=16).
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) 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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