Summit Biosciences Retained to Develop and Supply AT-301 Nasal Spray for Clinical Study
On May 28th, 2020, Atossa Therapeutics, Inc. announced their second COVID-19 therapeutic development program, AT-301 Nasal Spray. Summit Biosciences, located on the University of Kentucky's Coldstream Research Campus was retained to develop and produce a clinical supply of pre-filled nasal spray products in multi-dose devices containing AT-301.
AT-301 is Atossa’s proprietary formula intended for nasal administration in patients immediately following a diagnosis of COVID-19 but who have not yet exhibited symptoms severe enough to require hospitalization.
The next steps with the program include the designing 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 of 2020.
Founded in 2009, Summit Biosciences (www.summitbiosciences.com) is a specialized pharmaceutical company focused on developing, manufacturing, and commercializing generic and innovative nasal spray medicines. Summit Biosciences collaborates on the development of products with their clients and manufacturers at commercial scale for the US and European markets.
Atossa Therapeutics, Inc (www.atossatherapeutics.com) 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.
Contact:
Summit Biosciences, Inc.
UK Coldstream Research Campus
1513 Bull Lea Rd
Lexington, KY 40511
Tel: 859-254-0180
Contact:
Atossa Therapeutics, Inc.
Kyle Guse, CFO and General Counsel
Office: (866) 893-4927