On May 28, 2020, Atossa Therapeutics announced that it had begun the development of a second COVID-19 program using its proprietary drug candidate AT-301, to be administered by nasal spray.

AT-301 is Atossa’s proprietary formula intended for nasal administration in patients immediately following diagnosis of COVID-19 but who have not yet exhibited symptoms severe enough to require hospitalization. It is intended for at-home use to proactively reduce symptoms of COVID-19 and to slow the infection rate so that a person’s immune system can more effectively fight SARS-CoV-2 (coronavirus). Atossa also intends to conduct testing to determine whether AT-301 can be used as a prophylaxis to prevent or mitigate SARS-CoV-2, with the goal that it could become a “bridge to the vaccine” and be useful in the next phase of the coronavirus pandemic.

Atossa has retained Summit Biosciences, Inc., a pharmaceutical company with a proven track record in nasal spray medicines, to develop and produce a clinical supply of pre-filled nasal spray products in multi-dose devices containing AT-301 with the goal of commencing initial human clinical trials in the third quarter 2020.

Next steps with this program include the design and manufacturing of the clinical trial materials and the active pharmaceutical ingredients in AT-301 followed by adequate and well-controlled studies to demonstrate safety and efficacy. These studies must be successfully completed and regulatory approvals must be obtained before AT-301 may be commercialized. Atossa has filed provisional patent applications on AT-301 to treat patients diagnosed with, or to prevent, COVID-19 via nasal spray and intends to apply to the FDA as soon as possible so that human clinical trials may be commenced in the third quarter 2020.

Atossa Therapeutics 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.