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

About this update from Atossa Therapeutics, Inc.

[{"type":"text","content":"SEATTLE, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, with a current focus on breast cancer and COVID-19, 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. “We recently received input from the FDA on this program 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 2 study here in the United States.” Atossa also plans to develop its nasal spray to potentially help prevent COVID-19 infection -- particularly for people in high-risk environments, such as people living with an infected patient, people living and working in healthcare facilities, emergency responders or teachers. 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. New deadl...

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