Altamira Therapeutics Announces Publication of Positive Results from Bentrio Trial in Seasonal Allergic Rhinitis in Top Peer Reviewed Journal
24 Abril 2024 - 7:47AM
- Detailed results from randomized controlled Bentrio® trial in
seasonal allergic rhinitis published in Allergy journal
- Study met primary efficacy endpoint of improvement in nasal
symptoms (p = 0.013)
- Corroborated by statistically significant improvement in
health-related quality of life and reduced need for relief
medication
- Study outcomes support plans for further international
expansion
HAMILTON, BERMUDA -- April
24, 2024 -- Altamira Therapeutics Ltd.
(“Altamira” or the “Company”) (Nasdaq:CYTO), a company dedicated to
developing and commercializing RNA delivery technology for targets
beyond the liver, today announced the publication of the detailed
results from the NASAR clinical trial with Bentrio® nasal spray in
seasonal allergic rhinitis (SAR). The peer-reviewed article
appeared in Allergy,1 which is published by the European Academy of
Allergy and Clinical Immunology and recognizes as one of the
highest-ranking journals in the field of allergology. Bentrio
(AM-301) is a drug-free and preservative-free nasal spray designed
to help protect against airborne allergens such as pollen or house
dust mites.
The NASAR trial enrolled 100 patients during two
allergy seasons 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.
The primary efficacy endpoint was the reduction in the mean daily
reflective Total Nasal Symptom Score (rTNSS; ANCOVA model).
Bentrio-treated patients achieved a
significantly lower rTNSS than the saline group (least square means
difference -1.1, p = 0.013) with improvement observed across all
individual nasal symptoms. Health-related quality of life, as
measured by the Rhinoconjunctivitis Quality of Life Questionnaire
(RQLQ), was significantly improved as well (p < 0.001). Patients
and investigators rated the efficacy of treatment as significantly
better with Bentrio compared to saline control (both p < 0.001).
Both treatments showed similarly good safety and tolerability. With
Bentrio, fewer patients used relief medication and more enjoyed
symptom-free days compared to saline treatment.
“We are thrilled to see the detailed results
from our pivotal Australian trial published in one the leading
medical journals in allergology,” commented Thomas Meyer,
Altamira’s founder, Chairman, and CEO. “The study provided a wealth
of additional evidence for the protective effects of Bentrio as
well as its good safety and tolerability. 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. We would like
to thank all participating patients and study sites for their
contributions to the NASAR trial and look forward to making Bentrio
available in additional countries and helping patients who have to
deal with the daily burden and discomfort associated with allergic
rhinitis.”
Bentrio is marketed by Altamira Medica AG, an
associate company of Altamira Therapeutics, primarily through
distributors. From 2024 onwards, Altamira Medica expects sales to
grow significantly, mainly driven by the launch of Bentrio in
additional countries. The Company expects to conclude partnering
discussions and negotiations for distribution in the US, Europe and
other key markets in the course of 2024.
About Altamira Therapeutics
Altamira Therapeutics (Nasdaq: CYTO) is
developing and supplying peptide-based nanoparticle technologies
for efficient RNA delivery to extrahepatic tissues (OligoPhore™ /
SemaPhore™ platforms). The Company currently has two flagship siRNA
programs using its proprietary delivery technology: AM-401 for KRAS
driven cancer and AM-411 for rheumatoid arthritis, both in
preclinical development beyond in vivo proof of concept. The
versatile delivery platform is also suited for mRNA and other RNA
modalities and made available to pharma or biotech companies
through out-licensing. In addition, Altamira holds a 49% stake
(with additional economic rights) in Altamira Medica AG, its
commercial-stage legacy asset Bentrio®, an OTC nasal spray for
allergic rhinitis. Further, the Company is in the process of
partnering / divesting its inner ear legacy assets. Founded in
2003, Altamira is headquartered in Hamilton, Bermuda, with its main
operations in Basel, Switzerland. For more information, visit:
https://altamiratherapeutics.com/
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under the caption "Risk Factors" in Altamira’s Annual Report on
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Investor Contact:
Hear@altamiratherapeutics.com
1 Becker S, Deshmukh S, De Looze F, et al. AM-301, a
barrier-forming nasal spray, versus saline spray in seasonal
allergic rhinitis: A randomized clinical trial. Allergy.
2024;00:1-10. https://onlinelibrary.wiley.com/doi/10.1111/all.16116
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