Atossa Therapeutics announced that a two-week Phase 1 study evaluating the safety of two dose levels of the company’s AT-301 nasal spray in healthy volunteers demonstrated that the nasal spray was safe and well tolerated. The company announced in August 2020 that it had received approval for the Phase 1 trial of AT-301, which it is developing as an at-home treatment for COVID-19 and possibly for the prevention of COVID-19.
Atossa President and CEO Steven Quay commented, “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 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.”
According to Atossa, “The intended mechanism of action of AT-301 is to prevent virus entry into human cells by inhibiting the obligatory spike protein activation. The activation is performed by three human cell surface enzymes, ACE2, furin, and TMPRSS2, and is therefore unaffected by mutations and variants in SARS-CoV-2.”
Read the Atossa Therapeutics press release.