Atossa Therapeutics Seeks Clinical Investigation Approval From FDA To Launch The COVID-19 HOPE Study

The COVID-19 HOPE trial is the first pharmaceutical study to address getting patients off mechanical ventilator and reducing the high death rate
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SEATTLE, April 20, 2020 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), has applied to the FDA for approval to commence a clinical study of its proprietary drug, AT-H201, in COVID-19 patients on mechanical ventilation. AT-H201 is a novel formulation of two pharmaceuticals previously approved by the FDA for other diseases. The goal of the clinical trial, called the HOPE Study, is to demonstrate improved lung function and reduce the amount of time that COVID-19 patients are on ventilators. 

"One of the most tragic clinical features of the COVID-19 pandemic is the very high mortality rate for patients who require mechanical ventilation," stated Dr. Steven Quay, Atossa's President and CEO. "It is our hope that AT-H201 can have an impact in this clinical setting, both to save lives and to get patients off of the ventilator. Although there are over 100 clinical trials for COVID-19 being conducted in the United States, this is the first trial that I am aware of that is testing nebulized pharmaceuticals for patients on mechanical ventilation. Atossa looks forward to working on this important medical need and to reduce the death toll of COVID-19."

About Atossa's HOPE Study

The HOPE Study will assess the safety and efficacy of AT-H201 administered via inhalation in COVID-19 patients on mechanical ventilation support. Subject to FDA and IRB input, the study is currently designed as follows: At least thirty-nine patients will be enrolled in the active treatment group and compared to the outcome of 66 patients in a matched retrospective control group. Patients will be dosed with AT-H201 each day in addition to the standard of care while on mechanical ventilation for up to seven days and will be followed up throughout hospitalization and for 28 days after discharge. The primary objectives are to determine the number of ventilator-free days after patients are removed from ventilators following the initial airway intervention; oxygenation levels; and survival rates. Secondary efficacy endpoints include a variety of lung function parameters and time in ICU. Secondary safety endpoints include markers of coagulation. The trial will be registered at Clinical Trials Registration Site before the study commences. About Atossa's COVID-19 HOPE Program

Atossa's new program is called "COVID-19 HOPE," which is an acronym for AT- H 201in C O VID-19 patients for P ulmonary E valuation. The intended primary function of the drug combination AT-H201 is to essentially mimic the function of the antibodies formed from a vaccine by blocking the ability of the virus to enter the target cells; a vaccine that may not be available for more than a year. There are five known key steps the coronavirus must take to signal the cell to open up and let the virus in. AT-H201 is being designed to function like a "chemical vaccine" by blocking all five of those steps, similar to what antibodies would be expected to do when a vaccine is administered. With AT-H201, the virus should be unable to enter the cell because its "keys" that would otherwise open the door into the cell surface, are disabled. Atossa expects that its AT-H201 drug formulation, which will be tested for the first time in COVID-19 patients in the HOPE Study, can be developed more quickly than a traditional vaccine.

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. Atossa's current focus is on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com .

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 any variation between preliminary and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa's products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others, such as patent rights, potential market sizes for Atossa's drugs under development 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 Form10-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 kyle.guse@atossainc.com

Investor Relations Contact: Scott Gordon Core IR 377 Oak Street Concourse 2 Garden City, NY 11530 Office:516-222-2560 scottg@corprominence.com