- Fresh data from randomized controlled NASAR
clinical trial further demonstrate efficacy and tolerability of
Bentrio® nasal spray in treatment of seasonal allergic
rhinitis
- Study meets both primary and secondary efficacy
endpoints of improvement in reflective and instantaneous Total
Nasal Symptom Scores (p = 0.013 and 0.039)
- Corroborated by statistically significant
improvement in health-related quality of life secondary efficacy
endpoint (p < 0.001)
- Efficacy demonstrated from first day of 2-week
treatment period on and across allergy symptoms and functional
problems
- Bentrio treatment associated with reduced need
for relief medication
Altamira Therapeutics Ltd. (Nasdaq:CYTO), a
company dedicated to developing therapeutics that address important
unmet medical needs, today announced further positive and
statistically significant efficacy data from the randomized
controlled NASAR clinical trial, which evaluated their Bentrio
nasal spray in seasonal allergic rhinitis (SAR). Bentrio nasal
spray is formulated as a drug-free and preservative-free gel
emulsion designed to help protect against airborne allergens such
as pollen or house dust mites.
The NASAR trial enrolled 100 SAR patients in
Australia who were randomized at a 1:1 ratio to receive either
Bentrio or saline nasal spray, the current standard of care in
drug-free SAR management. Study participants self-administered the
treatment for two weeks three times per day, or as needed. For
eligibility, patients had to have a reflective Total Nasal Symptom
Score (rTNSS) of at least 5 points (out of 12), referring to the
worst level of nasal congestion, sneezing, nasal itching, and
rhinorrhea (runny nose) over the past 24 hours, during a one-week
treatment-free run-in period. At baseline, patients recorded on
average 6.9 points on the rTNSS scale, which is considered a
moderate level.
As previously reported, the NASAR trial met its
primary efficacy endpoint, with the Bentrio group showing a mean
rTNSS over the treatment period of 5.0 points vs. 6.1 points for
the saline spray group, resulting in a statistically significant
difference of 1.1 points in the ANCOVA model1 in favor of
Bentrio (LSmeans; p = 0.013; 95% confidence interval -2.0 to -0.2).
The reduction in nasal symptoms conferred by Bentrio was 2.4 times
larger than with saline nasal spray and clinically relevant. The
change in mean rTNSS over two weeks is generally accepted as a
primary efficacy endpoint for SAR trials and also recommended by
the FDA.
Additional data, which have become subsequently
available from the NASAR trial, confirm and reinforce the body of
evidence demonstrating Bentrio’s efficacy in SAR management. The
mean instantaneous TNSS (iTNSS), which measures nasal symptoms ‘at
the moment’ and served as a secondary efficacy endpoint, was 4.4
points and 4.8 points at baseline. At the end of the treatment
period, it reached 2.9 points in the Bentrio group vs. 3.7 points
in the placebo group. Like for the TNSS, the difference of 0.8
points in the ANCOVA model was significantly larger for the Bentrio
group (LSmeans; p = 0.039; 95% confidence interval -1.6 to -0.04).
The treatment effect in favor of Bentrio became apparent from the
first day of the two-week treatment period and was observed across
the four nasal symptoms covered by the TNSS. It was particularly
pronounced in patients with moderate to severe symptom
levels.
Importantly, the alleviation of symptoms was
associated with an improvement in health-related quality of life,
as measured by the Rhinoconjunctivitis Quality of Life
Questionnaire (RQLQ). The RQLQ has been designed to collect
information on functional problems caused by allergic rhinitis. At
baseline, the mean total RQLQ score was 3.0 points in the Bentrio
group and 2.8 points in the saline spray group and decreased to 1.7
points and 2.4 points, respectively, by Day 14. The difference in
improvement of 0.7 points in favor of Bentrio was statistically
significant in the ANCOVA model (LSmeans; p < 0.001; 95%
confidence interval -1.1 to -0.31) and clinically relevant. The
improvement in the Bentrio group was significantly superior for
each of the 8 RQLQ items, including nasal symptoms, eye symptoms,
non-nose/eye symptoms, activity limitations, sleep problems,
practical problems and emotional function.
Further, the read-out from the NASAR trial
suggest that Bentrio helps reduce the need for relief medication
(cetirizine nasal spray). Whereas a similar share of patients
required relief medication during the treatment-free run-in period,
more participants in the Bentrio group (11 out of 16; 68.7%) could
abstain from relief medication during the treatment period, but
only 4 out of 15 (26.6%) in the saline spray group. Within the
overall group of patients, 20.8% of Bentrio treated patients
required relief medication during treatment vs. 31.9% in the saline
spray group.
As previously announced, 73.5% of
Bentrio-treated study participants rated tolerability of the
treatment as either good or very good vs. 85.5% of saline-treated
participants. Among the latter, 10.4% reported tolerability as poor
vs. only 6.1% in the Bentrio group. Adverse events were relatively
rare (reported for 42.9 vs. 32.7%), mostly of mild severity and in
the majority considered unrelated.
“The further read-out from the NASAR trial has
provided a wealth of additional data, which apart from confirming
the good safety and tolerability of Bentrio, provide strong
evidence for its significant protective effects,” commented Thomas
Meyer, Altamira Therapeutics’ founder, Chairman, and CEO. “We are
particularly thrilled about the highly significant improvement in
health-related quality of life, which does matter a lot to patients
and complements nicely the significant reduction in nasal symptoms.
In addition, we are very encouraged to see that Bentrio helps to
manage not only mild allergy symptoms, but also more severe ones,
and appears to reduce the need for the use of drug-based relief
treatments.”
“With efficacy data that is approaching that of
medicated nasal sprays, yet a safety and tolerability profile that
is similarly favorable as for seawater nasal sprays, we believe
that Bentrio provides an attractive treatment option for patients
who have to deal with the daily burden and discomfort associated
with allergic rhinitis. Through partnering with strong and
dedicated marketing and distribution partners, we intend to make
Bentrio available to a growing number of patients world-wide and
help them to improve their condition and well-being.”
About Bentrio
Bentrio is an OTC drug-free nasal spray for
personal protection against airborne allergens and, where approved,
against airborne viruses. 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 allergens (or virus particles)
with cells; in addition, the composition serves to bind such
particles and help with their discharge. Together, this is designed
to promote alleviation of allergic symptoms (or mitigate upper
respiratory tract viral infections). For more info,
visit: https://altamiratherapeutics.com/legacy-programs/bentrio
About Altamira Therapeutics
Altamira (Nasdaq: CYTO) is dedicated to
developing RNA-based therapeutics for extrahepatic targets
(OligoPhore / SemaPhore delivery platforms). The Company currently
has two flagship siRNA programs in preclinical development beyond
in vivo proof of concept: AM-401 for KRAS driven cancer and AM-411
for rheumatoid arthritis. The versatile delivery platform is also
suited for mRNA and other types of RNA therapeutics and is planned
to be leveraged via out-licensing to pharma or biotech companies.
In addition, Altamira is in the process of divesting and/or
out-licensing its legacy assets in allergology and viral infection
(Bentrio OTC nasal spray; commercial) and inner ear therapeutics
(AM-125 nasal spray for vertigo; post Phase 2; Keyzilen® and
Sonsuvi® for tinnitus and hearing loss; Phase 3). Founded in 2003,
Altamira is headquartered in Hamilton, Bermuda, with its main
operations in Basel, Switzerland. For more information,
visit: https://altamiratherapeutics.com
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
Altamira Therapeutics' 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 success of the
continued commercialization of Bentrio and success of strategic
transactions, including licensing or partnering, with respect to
Bentrio or any other legacy assets, Altamira Therapeutics' 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 Altamira Therapeutics' product candidates, the
clinical utility of Altamira Therapeutics' product candidates, the
timing or likelihood of regulatory filings and approvals, Altamira
Therapeutics' intellectual property position and Altamira
Therapeutics' financial position, including the impact of any
future acquisitions, dispositions, partnerships, license
transactions or changes to Altamira Therapeutics' 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 Altamira Therapeutics' Annual
Report on Form 20-F for the year ended December 31, 2022, and in
Altamira Therapeutics' 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 Altamira Therapeutics or
to persons acting on behalf of Altamira Therapeutics 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 Altamira Therapeutics 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.
1 Using baseline rTNSS score, average use of
relief medication (cetirizine nasal spray) and treatment group as
covariates.
Hear@altamiratherapeutics.com
800-460-0183
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