HAMILTON, BERMUDA, Nov. 8, 2022 (GLOBE NEWSWIRE) — • A publication in the International Archives of Allergy and Immunology shows rapid onset and long duration of protective effects of Bentrio in patients with allergic rhinitis
• Mean increase in Total Nasal Symptom Score (TNSS) 1.1 points less vs. no protection, providing a clinically meaningful improvement
• Mean increase in TNSS 0.4 points less than established powder allergy blocker spray; Efficacy of Bentrio rated 2x more favorably by patients
• Safe and well tolerated treatment
Altamira Therapeutics Ltd. (NASDAQ:CYTO) (“Altamira” or the “Company”), a company dedicated to developing therapeutics that address significant unmet medical needs, announced today that the International Archives of Allergy and Immunology (IAAI) has published A -Reviewed article entitled “Efficacy and safety of a drug-free barrier-forming nasal spray for allergic rhinitis: a randomized, open-label, crossover non-inferiority trial.” The trial showed that BentrioTM (AM-301) relieved 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 overall efficacy ratings by study participants and clinicians. The treatment was safe and well tolerated. The trial results provided essential clinical data for obtaining marketing authorization from the US Food and Drug Administration (FDA), which occurred in June 2022.
Bentrio is an over-the-counter 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 be available in progressively more countries through a growing global network of distributors. As previously announced, the Company is seeking to divest or license Bentrio for key markets in North America and Europe.
“We are pleased to see the details on this exciting study published after peer review,” said Jean Lachance, director of Altamira Therapeutics’ OTC Consumer Health Business Unit. “Bentrio showed a persistent protective effect over four hours of pollen exposure, which was in line with the other barrier-forming nasal spray tested. We were very pleased with the faster onset of protection, which we believe was an important factor driving the superior overall efficacy rating by patients and investigators.
“With this study we had started the clinical trials of Bentrio, which has since expanded greatly,” added Mr. Lachance. “Earlier this year we announced positive results also under the house dust mite challenge, and our large NASAR trial with seasonal allergic rhinitis patients in Australia is moving towards an expected reading in the first half of 2023. At the same time “We look forward to seeing the results of our COVAMID trial with Bentrio in acute cases of COVID-19, which is expected later in the current fourth quarter.”
Bentrio was tested in an open-label, randomized crossover trial at the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) in Hannover, Germany in 36 patients with grass pollen allergic rhinitis. Subjects were first exposed to unprotected Dactylis glomerata pollen and then received protection from either Bentrio or a commercially available HPMC nasal spray, which served as the predicate device in the 510(k) filing with the FDA (7 days apart). Efficacy was assessed from total nasal symptom score (TNSS), nasal discharge weight, and a subjective global rating. The primary endpoint was the difference, between Bentrio and HPMC, in least squares mean change in TNSS over a 4-hour allergen exposure.
Under Bentrio treatment, participants reported a mean increase in total nasal symptom score (TNSS; averaged over 4 hours over 20-minute intervals) of 4.75 points, which was 1.11 points, and therefore significantly below TNSS levels when exposed to pollen without nasal spray protection (ANCOVA Least Squares 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 Bentrio’s effectiveness as “good” or “very good,” while study investigators gave that rating to 45.7% of participants. Under HMPC treatment, TNSS increased by an average of 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 effectiveness of the comparator as “good” or “very good,” while the study investigators provided that rating to 25.0% of participants. Bentrio showed significantly lower increases in TNSS than HPMC during the first 40 min of pollen exposure.
For the study’s primary endpoint, the difference in least squares means between the two treatments was -0.39 (95% CI, -0.89 to 0.10) in favor of Bentrio, establishing non-inferiority and therefore substantial equivalence with the predicate device. . Sixteen subjects reported adverse events related to AM-301 or HPMC; most adverse events were mild and none were serious. Overall tolerability was rated as good or very good by more than 80% of study participants for both devices.
About the International Archives of Allergy and Immunology
The International Archives of Allergy and Immunology provides a forum for experimental and clinical research in modern molecular and cellular allergology and immunology. The journal, which appears monthly, publishes original papers in the fields of allergy, immunopathology, immunogenetics, immunopharmacology, immunoendocrinology, tumor immunology, mucosal immunity, transplantation, and immunology of infectious and human diseases. conjunctive tissue. In addition to original articles, it features short communications, reviews, mini-reviews, comments, and opinions. A team of internationally renowned and committed editors ensures a fair review process, high scientific quality, and rapid dissemination of significant and novel work. For more information visit https://www.karger.com/Journal/Home/224161
Bentrio is a drug-free nasal spray for personal protection against airborne viruses and allergens. When applied to the nose, Bentrio forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent viruses or allergens from coming into contact with cells; moreover, the composition serves to bind said particles and help their discharge and to moisten the nasal mucosa. Together, this is designed to reduce the risk of viral upper respiratory tract infections and promote relief of allergy symptoms. For more information, visit: https://altamiratherapeutics.com/nuestros-productos/bentrio
Bentrio is distributed in select European and Asian countries and is expected to be available through distributors in other European, Asian and MENA countries. In the US, in June 2022, Altamira received FDA 510(k) clearance for Bentrio in the treatment of allergic rhinitis.
About Altamira Therapeutics
Altamira Therapeutics (Nasdaq: CYTO) is dedicated to developing therapies that address significant unmet medical needs. The company is currently active in three areas: the development of RNA therapies 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 therapies for the 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/.
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