Auris Medical Reports Positive In vitro Efficacy Data for AM-301 in Protecting Against Sars-CoV-2 Infection
December 01 2020 - 9:00AM
- Up to 99.4% reduction of viral titer in human epithelial cell
culture (p<0.001)
- Results suggest potential for AM-301 nasal spray to mitigate
risk of Sars-CoV-2 infection
Hamilton, Bermuda, December 1, 2020 – 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 positive efficacy data from testing
AM-301 in vitro. AM-301 is a drug-free nasal spray being developed
by the Company’s affiliate Altamira Medica for protection against
airborne pathogens and allergens.
AM-301 was tested for its capability to prevent
or mitigate SARS-CoV-2 infection of nasal epithelial cells, which
are part of the nasal mucosa and the first barrier against
continuously inhaled substances such as pathogens and allergens.
The experiment was performed over four days on reconstituted human
nasal epithelia, which are frequently used to study the effects of
human respiratory viruses. In saline-treated control cultures,
Sars-CoV-2 replicated efficiently, resulting in a rapid increase in
viral titer (as measured by the Median Tissue Culture Infectious
Dose, TCID50). In contrast, daily treatment with AM-301, beginning
right before inoculation, showed effective protection against viral
infection. 48 hours post-infection, average virus titers were 90.0%
lower than those observed in controls (p<0.05). 72 hours and 96
hours post-infection, average virus titers were 99.2 and 99.4%
lower, respectively (p<0.001). Even when unbound virus was not
removed daily through apical washing, allowing the virus to
accumulate in the culture for 4 days, the reduction in viral titer
was 92.4% compared to saline-treated controls (p<0.001).
“We are very excited to see the protective
effects of AM-301 against Sars-CoV-2 confirmed in an assay that
very closely replicates real-life conditions in the human nose“,
commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO.
“Our first experiments in September showed that AM-301’s key
component trapped up to 99% of Sars-CoV-2 when brought into contact
with a viral suspension. Now, with our newly developed spray
formulation, we have direct evidence that AM-301 has the potential
to significantly mitigate the risk of infection of nasal mucosal
cells. We look forward to taking AM-301 through additional tests
and advancing the program towards the submission of regulatory
applications in 2021.”
About AM-301
AM-301 is a drug-free nasal spray for personal
protection against airborne pathogens 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 other pathogens and allergens with cells; in
addition, the composition serves to “trap” 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 pathogens 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
- Auris Medical Altamira New Virus Protection Data
2020-12-01
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