Altamira Therapeutics (NASDAQ:CYTO) randomized the first patient in its NASAR trial for the clinical evaluation of Bentrio (AM-301) in seasonal allergic rhinitis (SAR).
Bentrio, a drug-free nasal spray intended for personal protection against airborne viruses and allergens, is marketed in several countries already.
The NASAR trial, which will enroll 100 SAR patients, is designed to compare the safety and efficacy of Bentrio against a saline nasal spray. Study participants will be randomized at a 1:1 ratio to either receive Bentrio or control treatment via self-administration three times a day, or as needed, for two weeks.
The primary endpoint will be comparison of the reflective Total Nasal Symptom Score under treatment with Bentrio against control. The NASAR trial is being conducted during the current pollen season at several study sites in Australia.
In a statement, Thomas Meyer, founder, chairman and CEO of Altamira, said that the company is looking forward to testing Bentrio’s protective effects against airborne allergens under real life conditions during pollen season in the southern hemisphere.
“Our previous study with controlled pollen exposure for four hours in an allergen challenge chamber had already demonstrated a rapid onset and long durability of Bentrio’s protective effect in allergic rhinitis,” he added. “We expect the NASAR study to reinforce and complement these earlier findings.”