Altamira Therapeutics reports efficacy outcome from Bentrio clinical trial

Altamira Therapeutics 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. 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. 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. 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, 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 . 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. 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 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. Whereas a similar share of patients required relief medication during the treatment-free run-in period, more participants in the Bentrio group could abstain from relief medication during the treatment period, but only 4 out of 15 in the saline spray group.