Altamira Therapeutics announced that the NASAR trial comparing its Bentrio bentonite-based gel nasal spray to saline nasal spray in patients with seasonal allergic rhinitis met its primary endpoint, demonstrating a statistically significant reduction in nasal allergy symptoms. The OTC nasal spray is currently available in Germany and has received 510(k) clearance in the US.
The trial enrolled 100 patients with a baseline rTNSS score of at least 5 out of 12. Participants used either Bentrio or saline nasal spray 2 to 3 times per day for 2 weeks. According to the company, patients using Bentrio experienced averaged a 1.9 point reduction on the reflective Total Nasal Symptom Score (rTNSS) compared to a 0.8 point reduction in rTNSS for patients using saline nasal spray. Altamira reports that 73.5% of patients in the Bentrio group reported the tolerability of the nasal spray as good or very good compared to reports of good or very good tolerability from 85.5% of the saline group.
Altamira Chairman and CEO Thomas Meyer commented, “We are thrilled with the strong outcomes from the NASAR trial, which we obtained under real-life conditions during the allergy season in Australia. The large magnitude of the reduction of nasal symptoms demonstrates that effective protection against seasonal allergic rhinitis is very well possible with a drug-free treatment. There are many patients who do not respond well to medicated nasal sprays either for lack of efficacy or due to tolerability issues with preservatives or other ingredients. I would like to extend my sincere appreciation to all the patients and investigators involved in the NASAR trial who helped us to reach this important clinical milestone.”
Meyer added, “With the completion of the NASAR trial, Altamira has concluded its clinical development of Bentrio in allergic rhinitis management. . . . Together with its marketing and distribution partners, Altamira is looking forward to making Bentrio available as an effective and safe treatment option to help patients deal with the daily burden and discomfort associated with allergic rhinitis.”
Read the Altamira Therapeutics press release.
