Atossa Therapeutics Seeks FDA Approval To Launch COVID-19 HOPE Study

(RTTNews) - Atossa Therapeutics, Inc. (ATOS), a clinical stage bio-pharmaceutical company, said Monday that it has sought approval from the U.S. Food and Drug Administration or FDA 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.

Atossa Therapeutics noted that 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.

Atossa's new program is called "COVID-19 HOPE," which is an acronym for AT-H201 in COVID-19 patients for Pulmonary Evaluation.

Subject to FDA and IRB input, at least thirty-nine patients will be enrolled in the trial's active treatment group and will be 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 of the trial are to determine the number of ventilator-free days after the patients are removed from ventilators following the initial airway intervention; oxygenation levels; and survival rates.

Secondary efficacy endpoints of the trial include a variety of lung function parameters and time in ICU.

"One of the most tragic clinical features of the COVID-19 pandemic is the very high mortality rate for patients who require mechanical ventilation. 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," said Dr. Steven Quay, Atossa's President and CEO.