Data Published in Peer-Reviewed Journal Demonstrate Protective Effects of Altamira’s Bentrio under Controlled Grass Pollen Exposure

Rhea-AI Summary

Altamira Therapeutics Ltd. (NASDAQ: CYTO) announced the publication of a peer-reviewed study in the International Archives of Allergy and Immunology on Bentrio, a drug-free nasal spray for allergic rhinitis. The study demonstrated Bentrio's rapid onset of action and superior efficacy compared to a marketed HPMC spray, with participants rating it twice as favorable. With FDA clearance obtained in June 2022, Bentrio is currently distributed in Europe and Asia, and plans for divestiture in North America and Europe are in progress.

Positive

• Bentrio demonstrated non-inferiority to a marketed spray with a faster onset of action.
• Clinical trial showed a 1.1 points reduction in Total Nasal Symptom Score (TNSS) versus no protection.
• Bentrio received FDA clearance in June 2022, facilitating market entry.

Negative

• None.

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
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 exercise by Zilentin AG of its option to purchase additional legacy assets, the achievement by Altamira of the milestones set forth in the option agreement with Zilentin, Altamira’s ability to complete a divestiture transaction of Bentrio, the approval and timing of commercialization of AM-301, 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, 2021, 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.

FAQ

What were the results of the clinical trial for Bentrio?

The trial showed significant reduction in TNSS, with an average score of 4.75 under Bentrio compared to 5.14 with HPMC.

When did Altamira receive FDA approval for Bentrio?

Altamira received FDA 510(k) clearance for Bentrio in June 2022.

What is Bentrio's market status?

Bentrio is available in several countries in Europe and Asia, with plans to expand distribution.

How did patients rate Bentrio compared to the marketed spray?

31.4% of participants rated Bentrio's efficacy as 'good' or 'very good', compared to 14.3% for the HPMC spray.

What future trials is Altamira working on for Bentrio?

Altamira is progressing with the NASAR trial in Australia and the COVAMID trial for acute COVID-19.