Additional significant efficacy outcomes announced from Bentrio clinical trial in seasonal allergic rhinitis

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 model 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 Rhino-conjunctivitis 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.

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.”