Auris Medical Announces Initiation of Clinical Investigation of AM-301 in Allergic Rhinitis
January 29 2021 - 08:30AM
Hamilton, Bermuda, January 29, 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 with its affiliate Altamira Medica AG
the initiation of a clinical investigation of AM-301 in allergic
rhinitis.
The clinical investigation is an open-label
randomized cross-over study that will enroll 36 patients with
allergic rhinitis to grass pollen. Study participants will be
administered a single dose of AM-301 nasal spray or a comparator
product (one puff into each nostril) prior to controlled pollen
exposure for four hours in an allergen challenge chamber. The
challenge will be repeated with the alternate treatment following a
wash-out period. The difference in the Total Nasal Symptom Score
(TNSS) between the two treatments over the 4-hour exposure will
serve as the primary efficacy endpoint; the investigation shall
demonstrate clinical non-inferiority of AM-301 to the comparator
product.
“We are very excited to initiate the clinical
investigation of AM-301 for its intended use of alleviating
allergic symptoms triggered by inhalation of airborne allergens,”
commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO.
“Allergic rhinitis from exposure to allergens such as pollen, house
dust or animal hair is affecting 7.8% of the adult US population
and 9% of children and can have a major impact on well-being and
quality of life. Despite its high prevalence, there is still no
cure for it. With AM-301, we are seeking to provide a simple,
drug-free and yet effective means for protection of the nasal
mucosa against airborne allergens.”
Results from the allergen challenge chamber
study are expected in Q2 2021. Beside the development of AM-301 for
use in allergy management, Altamira Medica is advancing the testing
of the nasal spray for use in the protection against infections
from airborne viruses such as SARS-CoV-2.
“Like all of us in the past few weeks, we have
been watching with growing concern the spreading of various
SARS-CoV-2 mutations around the world,” stated Thomas Meyer. “Given
AM-301’s mode of action and inherent broad spectrum, we are
confident that the nasal spray will exert protective effects also
in case of the new strains. For confirmation, we are planning to
test AM-301 against them in reconstituted human nasal epithelia
cells shortly.” The Company maintains its objective of introducing
AM-301 in selected markets in late Q2 2021.
About AM-301
AM-301 is a drug-free nasal spray for personal
protection against airborne viruses and allergens. Upon application
into the nose, AM-301 forms a protective gel layer on the nasal
mucosa. This thin film is designed to prevent the contact of
viruses or allergens with cells; in addition, the composition
serves to bind such particles and help with their discharge.
Together, this is designed to reduce the risk of upper respiratory
infections and promote alleviation of allergic symptoms.
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 a nasal spray for protection
against airborne viruses and allergens (AM-301). 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:
investors@aurismedical.com
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