Lexington company retained to develop and supply nasal spray for clinical study

SEATTLE — Lexington, Ky.-based Atossa Therapeutics Inc., 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, announced recently that it has 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 the 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.

“In April we launched our AT-H201 COVID-19 HOPE program for the most severely ill COVID-19 patients,” said Dr. Steven Quay, president and CEO of Atossa. “By contrast, our new AT-301 nasal spray program is being developed for the relatively healthier COVID-19 patients who have not been hospitalized. We are developing AT-301 with a nasal spray delivery mechanism because many COVID-19 patients are infected via the nasal passage. The mechanism of action is intended to inhibit essential human host proteases, which are found in abundance in the nasal mucosa, from activating the SARS-CoV-2 Spike Protein, the known first and obligatory step that must be taken before the virus can enter the body.”

“This may eventually be useful as a prophylactic, to be used before leaving the home. In that setting it would be intended to create a barrier inside the nose to prevent virus entry – sort of a short-term vaccine-like treatment that could be helpful before a true vaccine is available. Our goal with the two COVID-19 programs is to ultimately commercialize therapies for patients on both ends of the spectrum – from the healthier patients who will be treated at home and the sicker patients who require mechanical ventilation in the hospital,” said Dr. Quay.

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.

The 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.

ABOUT SUMMIT BIOSCIENCES

Founded in 2009, Summit Biosciences Inc. of Lexington, Ky. (www.summitbiosciences.com) is a privately-held, specialized pharmaceutical company focused on developing, manufacturing and commercializing generic and innovative nasal spray medicines. It collaborates on the development of products with its clients and manufactures them at an industrial scale primarily for commercialization in the U.S. and Europe.