Avance Clinical Client Atossa Therapeutics Announces Final Results from Phase 1 Clinical Study Showing Safety and Tolerability of AT-301 Nasal Spray Being Developed for COVID-19


The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical congratulated Atossa Therapeutics on the announcement of their Phase 1 final results for the AT-301 nasal spray being developed for COVID-19.

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19.

Yvonne Lungershausen, CEO, Avance Clinical said:

“As the CRO for this important study, we congratulate Atossa Therapeutics on these impressive safety and tolerability clinical results. Atossa Therapeutics have tapped the full scope of our CRO services including ClinicReady, our scientific and medical affairs specialist team. Australian clinical trials are recognized globally for their speed and accuracy and the fact that the clinical data is accepted by all major regulatory authorities including the FDA. Increasingly our clients are also tapping the generous 43.5% Australian Government rebate to support their clinical research.”

According to Atossa Therapeutics:

Atossa Therapeutics today announced final results from its Phase 1 double-blinded, randomized, placebo-controlled clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray. AT-301 was considered to be safe and well tolerated in healthy male and female participants in this study at two different dose levels over 14 days. AT-301 is being developed for at home use for patients recently diagnosed with COVID-19. There are currently no FDA-approved therapies to treat COVID-19 at home.

Final analysis of the data from the study indicates that there were no serious adverse events, no discontinuations, no bronchospasms, and only one subject of the 32 subjects in the study experienced adverse events that were considered moderate in severity and all other adverse events were considered mild.

Atossa’s assessment is that AT-301 nasal spray was safe and well tolerated in this study. The most common treatment-related adverse events observed with AT-301 treatment with either single or multiple doses were nasal discomfort and sneezing.

“The results from this study are very encouraging and we look forward to quickly commencing the next study of AT-301,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO.

Atossa believes that AT-301 nasal spray will play an important role alongside the traditional vaccines now being deployed, particularly as it becomes clear that it will take months or years for vaccines to be administered around the world.

The Phase 1 study was a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects who were divided into two study groups.

Part A consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A at two different doses. Part B was a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days at two different doses.

The primary objectives of the study were to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives were to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation.