Atossa Therapeutics said that preclinical testing of its AT-301 nasal spray in VERO cells has demonstrated that it can limit SARS-CoV-2 infectivity, and the company has contracted with Australian CRO Advance Clinical for a Phase 1 trial, which is expected to begin this quarter. The company also said that it has filed provisional patent applications in the US to cover the formulation, manufacturing, and methods of use of AT-301.
According to Atossa, “AT-301 is being designed to contain ingredients that can potentially block SARS-CoV-2 viral entry gene proteins in nasal epithelial cells by interfering with spike protein activation by host proteases, by masking receptor binding domains (RBD) via electrostatic mechanisms, and by providing a generalized mucoadhesive epithelial barrier.”
Atossa Pharmaceutical President and CEO Steven Quay commented, “The AT-301 formulation was designed to work like a mucosal vaccine, blocking entry of the virus into the cells to begin with and thus, hopefully, preventing a COVID-19 infection. With the finding that a particular cell found in the nasal cavity — the goblet cell — has among the highest expressions of viral entry genes, the concept of targeting the nasal cavity to block early SARS-CoV-2 infection made a lot of sense. And having invented two FDA-approved nasal spray products before founding Atossa, I am gratified to be able to bring this prior clinical and regulatory experience to bear on this devastating pandemic. We look forward to commencing a Phase 1 clinical study this quarter and reporting progress on this clinical development program.” Quay was previously CEO of nasal spray developer Nastech, which became MDRNA and then Marina Biotech.
Quay also said, “Our AT-301 nasal spray program is being developed for COVID-19 patients who are not hospitalized, which complements our AT-H201 program being developed for COVID-19 patients on ventilators. . . . We may eventually develop AT-301 as a prophylaxis to reduce risk of being infected with COVID-19. For example, it could be taken as a daily vaccine-like treatment for people at higher-risk, such as TSA workers, emergency medical professionals and hospital personnel.”
Read the Atossa press release on the preclinical results
Read the Atossa press release on the planned clinical trial
