Atossa Therapeutics Contracts for Clinical Study of AT-301 Nasal Spray, Atossa’s Second COVID-19 Therapeutic Development Program

SEATTLE, July 16, 2020 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), 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 that it has contracted with Avance Clinical Pty Ltd to conduct a clinical study of Atossa’s proprietary drug candidate AT-301, to be administered by nasal spray. Avance is a leading Australian clinical research organization and has successfully completed multiple clinical studies of Atossa’s proprietary Endoxifen.

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.

The study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups. Part A consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A. Part B is a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives are to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation.



“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,” commented Steven Quay, M.D., Ph.D., President and CEO of Atossa. “Many COVID-19 patients are infected via the nasal passage, which makes a nasal spray therapy potentially very attractive. Collectively, the components of AT-301 are believed to replicate a ‘vaccine-like mechanism’ to help maintain a protective mucosal barrier within the nasal cavity with anti-viral properties that may lead to lower infectivity and reduced symptoms in COVID-19 patients due to their interference with the spike protein of the virus in the nasal cavity and upper respiratory tract. 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,” concluded Dr. Quay.



An application to commence the study has been submitted to the relevant institutional review board (IRB) and local regulatory authority in Australia which must be approved before commencement of the study. Pending these approvals, Atossa expects that the study will commence this quarter.



Adequate and well-controlled studies to demonstrate safety and efficacy 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.



ABOUT ATOSSA THERAPEUTICS



Atossa Therapeutics, Inc. 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. For more information, please visit



ABOUT AVANCE CLINICAL PTY LTD



Avance Clinical Pty Ltd is a leading Australian CRO with a client portfolio that extends across North America, Canada, New Zealand, Asia and Europe. Avance Clinical is an Australian owned CRO that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. Its office is located in Adelaide, South Australia with employees operating across the major Australian states and New Zealand.



Avance Clinical specializes in working with biotech companies to execute Phase 1 and Phase 2 clinical trials. It is a full service CRO with services including clinical project management, clinical trial monitoring, drug safety reporting, medical writing, data management, statistical and pharmacokinetic services, and external auditing.



FORWARD-LOOKING STATEMENTS

Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with the following: whether in vitro test results will also be achieved in in vivo studies, including human clinical studies, actions by and interactions with the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence human clinical studies of AT-301 and the outcome of such trials, lower than anticipated rate of patient enrollment, the safety and efficacy of Atossa’s product candidates, performance of developers and manufacturers, clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, uncertainties affecting our ability to secure patent protection for AT-301 or AT-H201 and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.



Company Contact:

Atossa Therapeutics, Inc.

Kyle Guse, CFO and General Counsel

Office: (866) 893-4927





Investor Relations Contact:

Core IR

Office: (516) 222-2560





Source: Atossa Therapeutics, Inc.