Auris Medical Announces Randomization of First Patient in AM-125 Phase 2 Trial in Acute Vertigo
July 30 2019 - 8:30AM
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 its
“TRAVERS” Phase 2 trial of AM-125, the Company’s investigational
drug for the treatment of acute vertigo.
The TRAVERS trial will enroll a total of 138
patients who suffer from acute vertigo following surgical removal
of a vestibular schwannoma, a tumor growing behind the inner ear.
In Part A of the trial, five ascending doses of AM-125 or placebo,
administered three times daily over a total of four weeks, will be
tested in 50 patients. In addition, oral betahistine 48 mg will be
tested in 16 patients under open-label conditions for reference.
Based on an interim analysis, two doses will be selected and tested
in an estimated 72 patients in Part B of the trial. The TRAVERS
trial is being conducted in six European countries and Canada.
“After securing approvals from the numerous
regulatory authorities and ethics committees involved, we are
excited to start patient enrollment into the TRAVERS trial,”
commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO.
“With AM-125, we seek to improve and accelerate vestibular recovery
so that patients are back in control of their balance sooner, thus
improving their quality of life. Betahistine, the active substance
of AM-125, is known to promote vestibular compensation, and we
expect intranasal delivery to provide superior efficacy compared to
oral administration.”
As previously announced, Auris Medical’s second
development project with intranasal betahistine, AM-201, recently
completed enrollment for a Phase 1b proof-of-concept trial in the
prevention of antipsychotic-induced weight gain with top line data
expected for later in the third quarter of 2019.
The Company will provide its first-half 2019
results and a business update on August 15, 2019 at 8:00am Eastern
Time (2:00pm Central European Time). To participate in this
conference call, dial +1-866-966-1396 (toll free) or
+1-631-510-7495, and enter passcode 2228118. A live webcast of
the conference call can be accessed in the Investor Relations
section of the Auris Medical website
at www.aurismedical.com. A replay will be available
approximately two hours following the live call.
About AM-125
Intranasal betahistine is being developed under
project code AM-125 for the treatment of acute vertigo. Betahistine
acts as agonist at the H1 and as antagonist at the H3 histamine
receptors and 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. However, due to rapid and extensive metabolism,
bioavailability of oral betahistine is very low in humans, which
limits the treatment’s clinical utility. Intranasal administration
results in significantly higher betahistine concentrations in
blood, which in turn is expected to result in higher efficacy and
more rapid onset of action.
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 Group for
Auris Medical 646-653-7030 jgreen@edisongroup.com
or
investors@aurismedical.com
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