Auris Medical Announces Positive Interim Data from TRAVERS Phase 2 Study with AM-125 in Vertigo
September 03 2020 - 08:30AM
- Dose dependent improvement in balance tests over placebo in
Part A of TRAVERS trial
- Improvement 1.9 to 2.4 times greater with highest dose than
with placebo
- Trial to proceed with Part B to test AM-125 10 and 20 mg vs.
placebo
Hamilton, Bermuda, September 3, 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 positive top-line data from the interim analysis of
its Phase 2 “TRAVERS” trial with intranasal betahistine in vertigo
(AM-125).
The interim analysis was based on Part A of the
trial, which enrolled 33 patients suffering from vertigo following
neurosurgery who were treated with AM-125 1, 10 or 20 mg or placebo
(3 x daily) for four weeks. It demonstrated a dose-dependent
improvement in balance as well as good safety and tolerability of
ascending doses of AM-125. At the highest dose of 20 mg (3 x
daily), AM-125-treated patients improved their performance of the
“Tandem Romberg” and the “Standing on Foam” balance tests from
baseline to 14 days post-surgery (primary endpoint) on average 1.9
to 2.4 times more than placebo-treated patients (6.0 vs. 3.1 and
10.5 vs. 4.3 seconds, respectively). In contrast to placebo, the
improvement from baseline was statistically significant for AM-125
20 mg and for all active dose groups, respectively (p<0.02 and
p<0.01 to p<0.05, respectively). These positive results were
supported by similar improvements in additional efficacy measures,
including additional objective as well as clinician- and
patient-reported outcomes.
“We are very excited and encouraged by the good
safety and tolerability as well as the strong and consistent
signals of AM-125’s clinical efficacy observed in this first part
of the TRAVERS trial,” commented Thomas Meyer, Auris Medical’s
founder, Chairman and CEO. “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’. 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).1
We look forward to advancing the AM-125 program further in order to
bring this innovative nasal spray to patients.”
Based on the results from the interim analysis,
the two highest doses, 10 and 20 mg, were selected by the Company
to be tested against placebo in 72 patients in Part B of the trial.
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. The improvement in the “Standing on Foam”
test will become the sole primary efficacy endpoint. This test
measures how long patients are able to maintain balance on a foam
mat (to obscure proprioceptive input) with their eyes closed (to
eliminate visual input), relying primarily on vestibular input from
their inner ears. The improvement in the more challenging “Tandem
Romberg” test, which is performed with eyes closed and the two feet
to aligned one after the other, will become the key secondary
efficacy endpoint. Prior to starting Part B of the trial, 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, in Phase 2) and for the prevention of
antipsychotic-induced weight gain and somnolence (AM-201, post
Phase 1b). 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
1 Agrawal Y et al. (2009), Disorders of Balance and Vestibular
Function in US Adults - Data From the National Health and Nutrition
Examination Survey, 2001-2004, Arch Intern Med.
169(10):938-944.
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