Bentrio Nasal Spray alleviates symptoms of allergic rhinitis due to House Dust Mite

Symptoms resulting from allergy to house dust mites can be effectively alleviated by a nasal spray compared with no treatment, according to a press release issued by Altamira Therapeutics. According to the company the drug-free AM-301 (Bentrio, ) nasal spray forms a protective gel layer on the nasal mucosa after application and keeps viruses and allergens from coming in contact with cells.

The HDM challenge trial demonstrated a statistically significant reduction of nasal symptoms vs. untreated controls as well as good tolerability and safety. Bentrio is a drug-free nasal spray intended for personal protection against airborne viruses and allergens with a triple mode of action.

At a single Canadian study site, the trial enrolled a total of 37 patients with a history of perennial allergic rhinitis ("PAR") caused by HDM exposure. Study participants were randomized under an open label, three-period crossover design to receive either Bentrio in a single or double dose, or no treatment, prior to controlled allergen exposure in an environmental exposure chamber for three hours.

The primary endpoint was the change in the Total Nasal Symptom Score (TNSS; determined in 20-minute intervals) from baseline. The ANCOVA (analysis of covariance) model showed that Bentrio treatment reduced the increase in mean TNSS during the 3-hour exposure by 1.1 points (-1.87 to -0.28 in the 95% confidence interval; p<0.01) vs. no treatment. Under Bentrio treatment, the mean TNSS was 4.1 points vs. 5.2 points under no treatment.

The changes in TNSS started to separate at the 40-minute time point and, on average, reached 1.5 to 2 points from the mid-point to the end of exposure. The protective effect was observed both with a single or double puff per nostril with no meaningful difference between the two treatment approaches. Regarding safety, there were only few adverse events, mostly mild, and more than 85% of study participants rated the tolerability of Bentrio as "good" or "very good."

"We are delighted with the outcome from the house dust mite challenge study as it confirms Bentrio's ability to effectively and safely protect against various types of airborne allergens," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "The positive data from this perennial allergic rhinitis study is congruent with the favorable outcomes from our previous study of grass pollen in seasonal allergic rhinitis.

"Interestingly, we found that one puff per nostril is sufficient to achieve the desired protection," Mr. Meyer added. "We look forward to continuing the commercial roll-out of Bentrio, helping to provide relief for those many allergy sufferers who have been looking for an effective over-the-counter treatment without any drug or preservative ingredients."

Reference:

1 Calderon et al. (2015), Respiratory allergy caused by house dust mites: What do we really know?, J Allergy Clin Immunol 136(1):38-48.

2 Salo et al. (2014), Prevalence of allergic sensitization in the United States: results from the National Health and Nutrition Examination Survey (NHANES) 2005-2006. J Allergy Clin Immunol 134(2):350-9.