- BentrioTM meets
primary efficacy endpoint in clinical evaluation in allergic
rhinitis
- Clinically
relevant and significant reduction in nasal symptoms
- Superior
efficacy ratings by patients and clinicians
- Pre-submission
meeting with FDA supports 510(k) regulatory pathway
Hamilton, Bermuda, May 7, 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 announced additional details
on the outcomes from the clinical investigation of its BentrioTM
nasal spray in allergic rhinitis and provided an update on the
regulatory pathway in the US for the intended use in allergy.
BentrioTM
effectively
alleviates
allergy
symptoms in clinical pollen
challenge
BentrioTM was tested in an open-label randomized
cross-over trial in 36 patients with allergic rhinitis to grass
pollen. Study participants were administered a single dose of
BentrioTM 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. The study demonstrated a rapid onset and long
durability of Bentrio’s protective effect, established substantial
equivalence to the marketed comparator with superior efficacy
ratings by patients and clinicians, and showed good
tolerability.
Under treatment with BentrioTM, participants
reported a mean increase in the Total Nasal Symptom Score (TNSS;
averaged over 4 hours in 20 minute intervals) of 4.75 points, which
was 1.11 points and thus significantly below TNSS levels when
exposed to pollen without nasal spray protection (ANCOVA least
square means; 95% confidence interval, CI: -1.61 to -0.61). A
1-point reduction in the TNSS is considered clinically relevant.
31.4% of study participants rated the efficacy of BentrioTM as
“good” or “very good”, while study investigators provided such
rating for 45.7% of participants. Under treatment with the
comparator product, a powder spray based on
hydroxypropylmethylcellulose (HMPC), the TNSS increased on average
by 5.14 points, which was 0.71 points lower than when unprotected
(CI: -1.21 to -0.21). 14.3% of study participants rated the
efficacy of the comparator as “good” or “very good”, while study
investigators provided such rating for 25.0% of participants.
BentrioTM showed significantly lower increases in the TNSS than
HPMC especially during the early phase of pollen exposure, reaching
clinical relevance and suggesting a rapid onset of action.
As previously announced, BentrioTM met the
primary endpoint of substantial equivalence in the change of TNSS
relative to HPMC, which serves as a predicate device for the
planned 510(k) submission to the US Food and Drug Administration
(FDA). Final analyses show a difference of 0.4 points in favor of
BentrioTM (CI -0.89 to 0.10), confirming non-inferiority. Proof of
substantial equivalence to the predicate device is a key
requirement for market clearance in the US under the 510(k)
regulatory pathway. In addition, the study provided further
evidence for the favorable safety profile of BentrioTM; with the
exception of one case, all study participants rated the
tolerability favorably.
Pre-submission meeting with
FDA
On May 6, 2021, Altamira Medica met with the FDA
for a pre-submission meeting relating to a 510(k) pre-market
notification application. The Company expects to request regulatory
clearance for BentrioTM for the intended use in allergy under the
510(k) pathway. During the meeting, the Company obtained important
information needed to help finalize the submission package.
Importantly, the Agency indicated that the design of the pollen
challenge study appeared appropriate to support the planned 510(k)
submission.
“We are very delighted to have reached further
important milestones with our BentrioTM program”, commented Thomas
Meyer, Auris Medical’s founder, Chairman and CEO. “We are very
delighted by the positive outcomes from the pollen chamber study,
where BentrioTM provided rapid and effective protection for four
hours of challenging allergen exposure. In addition, we very much
appreciated the FDA’s feedback during the pre-submission meeting
and feel well positioned to advance the preparations for a 510(k)
submission. At the same time, we are on track to meet the essential
requirements for marketing the product in Europe under the CE mark
shortly. We intend to launch the commercialization of BentrioTM in
selected European countries towards the end of June 2021 through
various on- and offline distribution channels. Launch preparations
are in full swing.”
About
BentrioTM
BentrioTM (AM-301) is a drug-free nasal spray
for personal protection against airborne viruses and allergens.
Upon application into the nose, BentrioTM 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 BentrioTM (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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