Auris Medical Announces Publication of Data from Preclinical Studies with Bentrio™ Nasal Spray in Prevention and Mitigation...
July 14 2021 - 9:00AM
- Bentrio™ formulation well tolerated in vitro on human nasal
epithelium
- Up to 99% reduction of SARS-CoV-2
viral titer with prophylactic treatment vs. controls
- Viral titer reduced 12- or 14-fold
vs. controls when treatment started 24 or 30 h post infection
Hamilton, Bermuda, July 14, 2021 – Auris Medical
Holding Ltd. (NASDAQ: EARS), a company dedicated to addressing
unmet medical needs through RNA therapeutics, allergy and viral
infection protection, and inner ear therapeutics, today announced
additional preclinical data in a model of primary human nasal
airway epithelium from its Bentrio™ (AM-301) nasal spray
development program in SARS-CoV-2. AM-301 was found to be safe in
vitro, and it significantly decelerated viral titer growth in
experimental models of prophylaxis and mitigation. The manuscript
describing these preclinical data is available on a preprint server
at https://www.biorxiv.org/content/10.1101/2021.07.12.452021v1 and
will undergo scientific peer-review for potential publication.
“These data provide strong evidence for
Bentrio’s potential to help reduce the risk of SARS-CoV-2 infection
of human mucosal cells when used preventatively and to decelerate
its course when used shortly after its onset“, commented Thomas
Meyer, Auris Medical’s founder, Chairman and CEO. “Recently
published clinical data from an independent research group show
that targeting the nasal mucosa during the early stage of Covid-19
is an ideal strategy for preventing the propagation of SARS-CoV-2.1
We look forward to the imminent start of the market roll-out of our
Bentrio nasal spray to help address this current pandemic with a
novel drug-free means for self-protection.”
The preclinical studies were performed in a
well-established model of reconstituted nasal epithelium from human
donors (MucilAir™), which provides testing conditions that tend to
be more challenging than real-life conditions in the human nose.
AM-301 was studied to determine its compatibility with MucilAir™,
its efficacy in preventing MucilAir™ from being infected by
SARS-CoV-2, and its ability to mitigate an established infection in
MucilAir™ without any previous treatment. First, AM-301 had no
detrimental effects on MucilAir™ inserts despite repeated
application over 4 days: measures of tight junction integrity and
cytotoxicity support Bentrio’s safety and did not show any
significant difference between treated and control cultures. An
expected finding was that the ciliary beat frequency was slightly
reduced due to the viscosity of the formulation.
Prophylactic treatment with AM-301 was
protective against SARS-CoV-2 infection, as daily application of
the product starting 10 minutes prior to inoculation led to a 2-log
(99%) reduction in viral titer (Tissue Culture Infectious Dose;
TCID50) by Day 4 compared to controls. Inserts that received the
product daily, starting 24 or 30 h after viral infection, also had
a lower viral titer, corresponding to a 12- or 14-fold lower TCID50
at the end of the treatment. In a linear-effects mixed model with
log-transformed data, the time profile of SARS-CoV-2 infection was
significantly decelerated compared to controls both in case of
prophylactic treatment (t=5.49; p<0.001) and in case of
mitigation treatment starting 24 or 30 h post infection (t=3.68;
p<0.01).
As recently announced, Auris Medical’s affiliate Altamira Medica
Ltd. will start the market roll-out of Bentrio™ by launching it in
Germany. Bentrio™ will shortly become available through selected
online pharmacies; over the coming months, market coverage will be
expanded progressively through additional distribution channels and
in further countries.
About
Bentrio™
Bentrio™ (AM-301) is a drug-free nasal spray for
personal protection against airborne viruses and allergens. Upon
application into the nose, Bentrio™ 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 and to
humidify the nasal mucosa. Together, this is designed to reduce the
risk of upper respiratory tract viral infections and promote
alleviation of allergic symptoms. In human nasal epithelium cells
infected by SARS-CoV-2, Bentrio™ was shown to reduce the infectious
viral load by more than 99% when used for prevention. Further,
Bentrio™ was effective in slowing the growth of the viral titer
when treatment started only 24 or 30 hours after infection. In
allergy, a clinical investigation in a pollen challenge chamber
demonstrated a significant reduction in the main symptoms of
allergic rhinitis with the protective effect setting in rapidly and
lasting for 4 hours.
About Auris Medical
Auris Medical is dedicated to developing
therapeutics that address important unmet medical needs. The
Company is currently active in three areas: the development of RNA
therapeutics for extrahepatic therapeutic targets (OligoPhore™ /
SemaPhore™ platforms; preclinical), nasal sprays for protection
against airborne viruses and allergens (Bentrio™; pre-commercial)
or the treatment of vertigo (AM-125; Phase 2), and the development
of therapeutics for intratympanic treatment of tinnitus or hearing
loss (Keyzilen® and Sonsuvi®, Phase 3). 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.” The Company will change its name to “Altamira Therapeutics
Ltd.” and its ticker symbol to “CYTO”, subject to approval by a
Special General Meeting of shareholders to be held on July 21,
2021.
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, the approval and
timing of commercialization of AM-301, Auris Medical’s need for and
ability to raise substantial additional funding to continue the
development of its product candidates, 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, 2020, 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
1 Ahn JH et al. (2021), Nasal ciliated cells are primary targets
for SARS-CoV-2 replication in the early stage of COVID-19, J Clin
Invest. 131(13):e148517.
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