Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that its “NASAR” clinical trial with its Bentrio nasal spray for seasonal allergic rhinitis (SAR) has resumed the enrollment of study participants in Australia as its pollen season is starting up again.
The NASAR trial, which will enroll a total of 100 patients suffering from SAR, is designed to compare the safety and efficacy of Bentrio against a saline nasal spray. Study participants are randomized at a 1:1 ratio to either receive Bentrio or control treatment via self-administration three times per day, or as needed, for two weeks.
The primary endpoint will be the comparison of the reflective Total Nasal Symptom Score (rTNSS) under treatment with Bentrio against control.
The NASAR trial was initiated in fall of 2021. It was suspended in spring 2022 as the pollen season came to an end before the enrollment target could be met. Interim data from the trial were used in support of the 510(k) clearance of Bentrio by the US Food and Drug Administration (FDA).
“We are pleased to have the first patient randomized into the continuation of the NASAR trial as the annual pollen season starts in Australia,” commented CEO Thomas Meyer, “The NASAR study will be important to generate further ‘real life’ data from allergic rhinitis sufferers and compare them with outcomes from saline nasal spray, the currently most popular drug-free treatment option.
CYTO shares forged their way up less than a cent, or 2.8%, to 30 cents.
