Data Published in Peer-Reviewed Journal Demonstrate Protective Effects of Altamira’s Bentrio under Controlled Grass Pollen Exposure
HAMILTON, BERMUDA, Nov. 08, 2022 (GLOBE NEWSWIRE) — • Publication in International Archives of Allergy and Immunology shows rapid onset and long duration of Bentrio’s protective effects in allergic rhinitis sufferers
• Mean increase of total nasal symptom score (TNSS) 1.1 points lower vs. no protection, providing clinically meaningful improvement
• Mean increase of TNSS 0.4 points lower vs. established powder allergy blocker spray; Bentrio efficacy rated 2x more favorably by patients
• Treatment safe and well tolerated
Altamira Therapeutics Ltd. (NASDAQ:CYTO) (“Altamira” or the “Company”), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that the International Archives of Allergy and Immunology (IAAI) has published a peer-reviewed article titled, “Efficacy and safety of a drug-free, barrier-forming nasal spray for allergic rhinitis: randomized, open-label, crossover noninferiority trial.” The trial showed that BentrioTM (AM-301) alleviated allergic nasal symptoms during controlled exposure to grass pollen for four hours.
Compared to a marketed nasal spray based on hydroxypropylmethylcellulose (HMPC) powder, Bentrio showed non-inferiority with faster onset of action and superior global efficacy ratings by study participants and clinicians. The treatment was safe and well tolerated. The results from the trial provided essential clinical data for obtaining market clearance by the US Food and Drug Administration (FDA), which occurred in June 2022.
Bentrio is an OTC drug-free nasal spray designed for personal protection against airborne allergens and, where approved, viruses. It is already being distributed in several countries in Europe and Asia and is expected to become available in progressively more countries through a growing global network of distributors. As previously announced, the Company is seeking to divest or out-license Bentrio for key markets in North America and Europe.
“We’re pleased to see details about this exciting study published following peer review,” said Jean Lachance, Head of Altamira Therapeutics’ OTC Consumer Health Business Unit. “Bentrio showed a persisting protective effect over the four hours of pollen exposure, which was in line with the other tested barrier-forming nasal spray. We were very pleased by the more rapid onset of protection, which we believe was a major factor driving the superior overall rating of efficacy by patients and investigators.
“With this study we had initiated the clinical testing of Bentrio, which since then has greatly expanded,” Mr. Lachance added. “Earlier this year, we announced positive outcomes also under house dust mite challenge, and our large NASAR trial with sufferers from seasonal allergic rhinitis in Australia is progressing towards an expected read-out in the first half of 2023. At the same time, we are looking forward to seeing the results from our COVAMID trial with Bentrio in acute COVID-19, which are expected later in the current fourth quarter.”
Study Highlights
Bentrio was tested in an open-label randomized cross-over trial at the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) in Hannover (Germany) in 36 patients with allergic rhinitis to grass pollen. Subjects were first exposed to Dactylis glomerata pollen without protection and then received protection by Bentrio or a marketed HPMC nasal spray, which served as predicate device in the 510(k) submission to the FDA (7 days apart). Efficacy was assessed from total nasal symptom score (TNSS), nasal secretion weight, and a subjective global rating. The primary endpoint was the difference, between Bentrio and HPMC, in the least square mean change in TNSS over a 4-hour exposure to the allergen.
Under treatment with Bentrio, 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 Bentrio as “good” or “very good”, while study investigators provided such rating for 45.7% of participants. Under treatment with 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. Bentrio showed significantly lower increases in the TNSS than HPMC during the first 40 minutes of pollen exposure.
For the primary endpoint of the study, the difference in the least-square means between the two treatments was -0.39 (95% CI, -0.89 to 0.10) in favor of Bentrio, establishing non-inferiority and thus substantial equivalence to the predicate device. Sixteen subjects reported adverse events with a relationship to AM-301 or HPMC; most adverse events were mild, and none was serious. Overall tolerability was rated as good or very good by over 80% of study participants for both devices.
About the International Archives of Allergy and Immunology
International Archives of Allergy and Immunology provides a forum for experimental and clinical research in modern molecular and cellular allergology and immunology. Appearing monthly, the journal publishes original work in the fields of allergy, immunopathology, immunogenetics, immunopharmacology, immunoendocrinology, tumor immunology, mucosal immunity, transplantation, and immunology of infectious and connective tissue diseases. In addition to original papers, it features short communications, reviews, mini-reviews, commentaries, and opinions. A team of internationally renowned and committed editors guarantees a fair review process, high scientific quality, and fast dissemination of significant and novel work. For more info, visit https://www.karger.com/Journal/Home/224161
About Bentrio™
Bentrio 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. For more info, visit: https://altamiratherapeutics.com/our-products/bentrio
Bentrio is being distributed in selected European and Asian countries and is expected to become available through distributors in further countries in Europe, Asia and MENA. In the US, in June 2022 Altamira received FDA 510(k) clearance of Bentrio in the treatment of allergic rhinitis.
About Altamira Therapeutics
Altamira Therapeutics (Nasdaq: CYTO) 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; commercial) or for 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). Founded in 2003, it is headquartered in Hamilton, Bermuda. For more information, visit: https://altamiratherapeutics.com/.
Forward-looking Statements
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