Atossa Therapeutics has reported positive final results from the Phase I clinical study of AT-301 nasal spray being developed to reduce Covid-19 symptoms in patients already diagnosed with the disease.
The company conducted a double-blinded, randomised, placebo-controlled clinical study on 32 healthy adult subjects to assess the safety and tolerability of the nasal spray at two different dose levels.
Based on final data, AT-301 showed to be safe and well tolerated in healthy male and female participants with only one person experiencing adverse events that were considered moderate in severity.
The most common side effects that were observed with single or multiple doses of the spray were nasal discomfort and sneezing.
Atossa president and CEO Steven Quay said: “The results from this study are very encouraging and we look forward to quickly commencing the next study of AT-301.
“We recently received input from the FDA on this programme and based in part on that input, we are now preparing to conduct an additional pre-clinical study, which we expect to start this quarter. Following that, we expect to apply to the FDA to commence a Phase II study here in the US.”
During the study, the subjects were divided into two study groups.
The Part A comprised two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A at two different doses, while the cohorts in Part B received either AT-301A or AT-301B for 14 days at two different doses.
The study was conducted in Australia.
As a clinical-stage biopharmaceutical company, Atossa seeks to develop medicines in areas of oncology and infectious diseases.
The company plans to further develop the nasal spray to potentially help prevent Covid-19 infection in high-risk environments.