Altamira Therapeutics Announces Publication of Positive Results from Bentrio Trial in Seasonal Allergic Rhinitis in Top Peer Reviewed Journal

Rhea-AI Summary

Altamira Therapeutics announces positive results from the Bentrio trial in seasonal allergic rhinitis, with statistically significant improvements in nasal symptoms, quality of life, and reduced need for relief medication. The publication in a top peer-reviewed journal validates the effectiveness and safety of Bentrio, supporting plans for international expansion.

Positive

• Statistically significant improvement in nasal symptoms with Bentrio compared to saline nasal spray
• Positive impact on health-related quality of life with Bentrio treatment
• Reduced need for relief medication with Bentrio
• Study outcomes support plans for further international expansion
• Recognition in a top peer-reviewed journal adds credibility to Altamira's RNA delivery technology

Negative

• None.

Insights

Medical Research Analyst

The recent publication of the NASAR clinical trial results for Bentrio in a top-ranking allergology journal indicates not only a scientific validation but also a potential market expansion for Altamira Therapeutics. The data pointing to Bentrio's efficacy in reducing nasal symptoms and improving quality of life, paired with a good safety profile, could sway prescribers towards recommending this drug-free treatment. From an investor's perspective, the confirmation of Bentrio's effectiveness is a persuasive element for its potential uptake in new markets. As the company sets eyes on the international expansion, one should closely watch the corporate execution on these plans, partnership formations and market entry strategies which will be critical in translating these positive trial outcomes into tangible revenue growth.

Market Research Analyst

Altamira's strategic emphasis on distribution partnerships for Bentrio could address the expanding demand for non-drug allergy management solutions, tapping into a consumer base that is increasingly seeking alternatives to traditional pharmacotherapy. The positive trial results may strengthen the product's market positioning and brand credibility, which is important in the crowded OTC allergy space. Investors should monitor the consumer adoption trends post-launch in new markets, as well as the effectiveness of Altamira's marketing campaigns, to gauge the trajectory of sales growth and market penetration which will ultimately drive the stock's performance.

Financial Analyst

With Altamira Medica's anticipation of significant sales growth driven by Bentrio's expansion, critical financial metrics to watch include the company's sales volume, revenue growth and market share in the allergy segment. The cost structure around new market entrances will also be insightful. It will be essential to analyze the pricing strategy for Bentrio, especially as the company navigates different healthcare systems, competition and consumer purchasing power across international markets. The impact on the company's profitability margins and earnings will offer a clearer picture of financial health to investors.

Hamilton, Bermuda, April 24, 2024 (GLOBE NEWSWIRE) --

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• 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/

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, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira’s 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 strategic transactions, including licensing or partnering, with respect to Altamira’s legacy assets, Altamira’s need for and ability to raise substantial additional funding to continue the development of its product candidates, the clinical utility of Altamira’s product candidates, the timing or likelihood of regulatory filings and approvals, Altamira’s intellectual property position and Altamira’s financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira’s 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’s Annual Report on Form 20-F for the year ended December 31, 2023, and in Altamira’s other filings with the Securities Exchange Commission (“SEC”), which are available free of charge on the SEC’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 or to persons acting on behalf of Altamira 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 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.

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   

FAQ

What are the primary efficacy endpoints met in the Bentrio trial for seasonal allergic rhinitis?

The primary efficacy endpoint of improvement in nasal symptoms was met with a statistically significant difference compared to the saline group (p = 0.013).

What journal published the detailed results of the Bentrio trial?

The detailed results were published in Allergy, a top peer-reviewed journal in the field of allergology.

What is the purpose of Bentrio nasal spray in seasonal allergic rhinitis?

Bentrio is a drug-free and preservative-free nasal spray designed to protect against airborne allergens like pollen or house dust mites.

How did patients rate the efficacy of Bentrio compared to the saline control?

Patients and investigators rated the efficacy of Bentrio treatment significantly better compared to the saline control (p < 0.001).

What are the future plans for Bentrio's international expansion?

The positive study outcomes support plans for further international expansion of Bentrio, with discussions for distribution in the US, Europe, and other key markets ongoing in 2024.