- Clinical evaluation of AM-301 nasal spray in allergic rhinitis
meets primary endpoint
- Extended protection achieved over several hours
- Preliminary preclinical data suggest therapeutic utility post
SARS-CoV-2 infection
- Product launch under BentrioTM brand in selected European
countries towards end of Q2 2021
Hamilton, Bermuda, April 13, 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, and its affiliate Altamira Medica Ltd. today provided an
update on its AM-301 program for protection against airborne
viruses and allergens.
“We are very pleased to report on major progress
with our AM-301 nasal spray program, which is moving in large steps
forward towards the start of commercialization”, commented Thomas
Meyer, Auris Medical’s founder, Chairman and CEO. “AM-301 has been
designed to provide a triple protective effect by acting as a
protective layer on the nasal mucosa, trapping and helping to
remove airborne particles and through humidification of the mucosa.
Fresh preclinical and clinical data confirm AM-301’s protective
effects in case of exposure to airborne allergens and suggest
potential utility of the product also in case of ongoing infection
from SARS-CoV-2. We have numerous additional studies ongoing or
planned and look forward to sharing further outcomes, including
through scientific communications.”
AM-301 effectively alleviates allergy
symptoms in clinical pollen challenge
Altamira Medica recently completed the treatment
phase of its open-label randomized cross-over clinical
investigation of AM-301 in 36 patients with allergic rhinitis to
grass pollen. Study participants were administered a single dose of
AM-301 nasal spray or a comparator product prior to controlled
pollen exposure for four hours in an allergen challenge chamber.
The challenge was repeated with the alternate treatment following a
wash-out period. Preliminary analyses show that AM-301 met the
primary endpoint of non-inferiority in the Total Nasal Symptom
Score (TNSS) relative to the marketed comparator product, which
serves as the predicate device for the planned 510(k) submission to
the US Food and Drug Administration (FDA). In addition, the
treatment was well tolerated. Proof of substantial equivalence to
the predicate device is a key requirement for market clearance
under the 510(k) regulatory pathway.
Furthermore, the allergen challenge study
demonstrated a rapid onset and long durability of AM-301’s
protective effect, as measured by a clinically relevant 1-point
reduction in the TNSS compared to unprotected pollen exposure. On
average, the protective effect was maintained for at least three
hours. These clinical observations are in line with the results
from a new in vitro study based on a barrier diffusion model. The
assay, which was performed at 35°C and 90% relative humidity to
mimic conditions within the nasal cavity, showed that a thin layer
of AM-301 prevented Timothy grass pollen from diffusing into an
agar block for up to 6 hours, the maximum duration of the
experiment.
AM-301 helps to reduce growth in
infectious titer in ongoing SARS-CoV-2 infection
In parallel with the outcomes from the allergy
studies, Altamira Medica obtained first data from testing AM-301
after the start of infection of human nasal epithelium cells with
SARS-CoV-2. In a previous study in the same type of assay, AM-301
had been shown to be highly effective in reducing the infectious
viral titer when daily treatment was started right before
inoculation of the cells, i.e. in a preventative fashion. In the
new experiment, daily treatment with AM-301 started 24 or 30 hours
post inoculation. Saline- and vehicle-treated and untreated cell
cultures served as controls.
In control cultures, SARS-CoV-2 replicated
efficiently over four days, resulting in a rapid increase in viral
titer (as measured by the Median Tissue Culture Infectious Dose,
TCID50, in Vero cells). Daily treatment with AM-301 resulted in a
statistically significant deceleration of the viral titer growth
compared to controls (p-value <0.01, linear mixed-effects
model). At Day 4 of the experiment, viral titers were 73.7 to 94.5%
lower compared to controls.
Selection of BentrioTM brand name for
commercialization
With the ongoing progress in the development and
testing of AM-301, the Company expects to meet the essential
requirements for marketing the product in Europe under the CE mark
shortly. Altamira Medica intends to launch the commercialization of
AM-301 under the brand name BentrioTM in selected European
countries starting in June 2021, employing various on- and offline
distribution channels. The Company expects to expand market
coverage rapidly during the second half of 2021, including
collaborations with future licensing partners. The expansion will
be supported by significant, scalable contract manufacturing
capacity.
Upon readiness for CE mark conformity, Altamira
Medica expects to submit a 510(k) pre-market notification
application to the FDA requesting regulatory clearance for AM-301
for the intended use in allergy. Regarding the intended use in
viral infections, the Company continues to be engaged in a dialogue
with the FDA on the applicable regulatory pathway.
Conference Call &
Webcast
Auris Medical's management team will host a live
conference call and webcast to present a business update on the
AM-301 program at 8:00 am Eastern Time (2:00 pm Central European
Time). To participate in this conference call, dial +1-877-870-9135
(US, toll free) or +44-2071-928-338 (international), and enter
passcode 5649276. 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-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 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.
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, 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
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