Altamira Therapeutics Reports Additional Significant Efficacy Outcomes from Bentrio Clinical Trial in Seasonal Allergic Rhinitis
HAMILTON, BERMUDA , Sept. 14, 2023 (GLOBE NEWSWIRE) --
- Fresh data from randomized controlled NASAR clinical trial further demonstrate efficacy and tolerability of Bentrio® nasal spray in treatment of seasonal allergic rhinitis
- Study meets both primary and secondary efficacy endpoints of improvement in reflective and instantaneous Total Nasal Symptom Scores (p = 0.013 and 0.039)
- Corroborated by statistically significant improvement in health-related quality of life secondary efficacy endpoint (p < 0.001)
- Efficacy demonstrated from first day of 2-week treatment period on and across allergy symptoms and functional problems
- Bentrio treatment associated with reduced need for relief medication
Altamira Therapeutics Ltd. (Nasdaq:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced further positive and statistically significant efficacy data from the randomized controlled NASAR clinical trial, which evaluated their Bentrio nasal spray in seasonal allergic rhinitis (SAR). Bentrio nasal spray is formulated as a drug-free and preservative-free gel emulsion designed to help protect against airborne allergens such as pollen or house dust mites.
The NASAR trial enrolled 100 SAR patients 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, or as needed. For eligibility, patients had to have a reflective Total Nasal Symptom Score (rTNSS) of at least 5 points (out of 12), referring to the worst level of nasal congestion, sneezing, nasal itching, and rhinorrhea (runny nose) over the past 24 hours, during a one-week treatment-free run-in period. At baseline, patients recorded on average 6.9 points on the rTNSS scale, which is considered a moderate level.
As previously reported, the NASAR trial met its primary efficacy endpoint, with the Bentrio group showing a mean rTNSS over the treatment period of 5.0 points vs. 6.1 points for the saline spray group, resulting in a statistically significant difference of 1.1 points in the ANCOVA model1 in favor of Bentrio (LSmeans; p = 0.013; 95% confidence interval -2.0 to -0.2). The reduction in nasal symptoms conferred by Bentrio was 2.4 times larger than with saline nasal spray and clinically relevant. The change in mean rTNSS over two weeks is generally accepted as a primary efficacy endpoint for SAR trials and also recommended by the FDA.
Additional data, which have become subsequently available from the NASAR trial, confirm and reinforce the body of evidence demonstrating Bentrio’s efficacy in SAR management. The mean instantaneous TNSS (iTNSS), which measures nasal symptoms ‘at the moment’ and served as a secondary efficacy endpoint, was 4.4 points and 4.8 points at baseline. At the end of the treatment period, it reached 2.9 points in the Bentrio group vs. 3.7 points in the placebo group. Like for the TNSS, the difference of 0.8 points in the ANCOVA model was significantly larger for the Bentrio group (LSmeans; p = 0.039; 95% confidence interval -1.6 to -0.04). The treatment effect in favor of Bentrio became apparent from the first day of the two-week treatment period and was observed across the four nasal symptoms covered by the TNSS. It was particularly pronounced in patients with moderate to severe symptom levels.
Importantly, the alleviation of symptoms was associated with an improvement in health-related quality of life, as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). The RQLQ has been designed to collect information on functional problems caused by allergic rhinitis. At baseline, the mean total RQLQ score was 3.0 points in the Bentrio group and 2.8 points in the saline spray group and decreased to 1.7 points and 2.4 points, respectively, by Day 14. The difference in improvement of 0.7 points in favor of Bentrio was statistically significant in the ANCOVA model (LSmeans; p < 0.001; 95% confidence interval -1.1 to -0.31) and clinically relevant. The improvement in the Bentrio group was significantly superior for each of the 8 RQLQ items, including nasal symptoms, eye symptoms, non-nose/eye symptoms, activity limitations, sleep problems, practical problems and emotional function.
Further, the read-out from the NASAR trial suggest that Bentrio helps reduce the need for relief medication (cetirizine nasal spray). Whereas a similar share of patients required relief medication during the treatment-free run-in period, more participants in the Bentrio group (11 out of 16; 68.7%) could abstain from relief medication during the treatment period, but only 4 out of 15 (26.6%) in the saline spray group. Within the overall group of patients, 20.8% of Bentrio treated patients required relief medication during treatment vs. 31.9% in the saline spray group.
As previously announced, 73.5% of Bentrio-treated study participants rated tolerability of the treatment as either good or very good vs. 85.5% of saline-treated participants. Among the latter, 10.4% reported tolerability as poor vs. only 6.1% in the Bentrio group. Adverse events were relatively rare (reported for 42.9 vs. 32.7%), mostly of mild severity and in the majority considered unrelated.
“The further read-out from the NASAR trial has provided a wealth of additional data, which apart from confirming the good safety and tolerability of Bentrio, provide strong evidence for its significant protective effects,” commented Thomas Meyer, Altamira Therapeutics’ founder, Chairman, and CEO. “We are particularly thrilled about the highly significant improvement in health-related quality of life, which does matter a lot to patients and complements nicely the significant reduction in nasal symptoms. 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.”
“With efficacy data that is approaching that of medicated nasal sprays, yet a safety and tolerability profile that is similarly favorable as for seawater nasal sprays, we believe that Bentrio provides an attractive treatment option for patients who have to deal with the daily burden and discomfort associated with allergic rhinitis. Through partnering with strong and dedicated marketing and distribution partners, we intend to make Bentrio available to a growing number of patients world-wide and help them to improve their condition and well-being.”
Bentrio is an OTC drug-free nasal spray for personal protection against airborne allergens and, where approved, against airborne viruses. 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 allergens (or virus particles) with cells; in addition, the composition serves to bind such particles and help with their discharge. Together, this is designed to promote alleviation of allergic symptoms (or mitigate upper respiratory tract viral infections). For more info, visit: https://altamiratherapeutics.com/legacy-programs/bentrio
About Altamira Therapeutics
Altamira (Nasdaq: CYTO) is dedicated to developing RNA-based therapeutics for extrahepatic targets (OligoPhore / SemaPhore delivery platforms). The Company currently has two flagship siRNA programs in preclinical development beyond in vivo proof of concept: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis. The versatile delivery platform is also suited for mRNA and other types of RNA therapeutics and is planned to be leveraged via out-licensing to pharma or biotech companies. In addition, Altamira is in the process of divesting and/or out-licensing its legacy assets in allergology and viral infection (Bentrio OTC nasal spray; commercial) and inner ear therapeutics (AM-125 nasal spray for vertigo; post Phase 2; Keyzilen® and Sonsuvi® for tinnitus and hearing loss; Phase 3). 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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1 Using baseline rTNSS score, average use of relief medication (cetirizine nasal spray) and treatment group as covariates.