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Atossa Therapeutics Contracts with NYC Health + Hospitals/Metropolitan for COVID-19 HOPE Clinical Study
Study Designed to Evaluate Atossa’s Combination Therapy AT-H201 to Reduce Patient Time on a Ventilator SEATTLE, April 27, 2020 (GLOBE NEWSWIRE) -- Atossa
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"Study Designed to Evaluate Atossa’s Combination Therapy AT-H201 to Reduce Patient Time on a Ventilator\nSEATTLE, April 27, 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, today announced that it has contracted with NYC Health + Hospitals/Metropolitan in New York City to conduct the NY HOPE Study of Atossa’s proprietary combination drug therapy called AT-H201. The NY HOPE Study will evaluate AT-H201 in COVID-19 patients on ventilators with the goal of reducing the amount of time on ventilators.\n “We are honored to be working with NYC Health + Hospitals/Metropolitan and Dr. Getaw Hassen, who are on the front lines of this unprecedented health crisis,” stated Dr. Steven Quay, President and CEO of Atossa Therapeutics. “The NY HOPE Study is a vital step in developing this new therapy for critically ill COVID-19 patients.” “Managing patient care and ventilator use has become a major challenge,” commented Getaw Hassen, M.D., Ph.D., Emergency Physician, at NYC Health + Hospitals/Metropolitan and the principal investigator of the NY HOPE Study. “We have an urgent need for a therapy to reduce reliance on ventilators and we are looking forward to playing a key role in what could be a much-needed solution for our sickest COVID patients.” The NY 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: Thirty-nine patients will be enrolled in the active treatment group and compared to the outcomes 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 during 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 and system function....