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COVID-19 HOPE Clinical Study Update: Atossa Therapeutics (ATOS) Contracts with NYC Health + Hospitals/Metropolitan

By John F. Heerdink, Jr.
“Managing patient care and ventilator use has become a major challenge. 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.” commented Getaw Hassen, M.D., Ph.D., Emergency Physician, at NYC Health + Hospitals/Metropolitan and the principal investigator of the NY HOPE Study. NYC Health + Hospitals/Metropolitan is the community hospital of choice for residents of East Harlem, northern Manhattan, and neighboring communities. NYC Health + Hospitals/Metropolitan provides culturally sensitive primary and specialized medical care to patients of all ages regardless of national origin, immigration status, or ability to pay. Since its founding in 1875, the hospital has been affiliated with New York Medical College, representing the oldest partnership between a hospital and a private medical school in the United States. NYC Health + Hospitals/Metropolitan is part of the NYC Health + Hospitals public health care system. For more information, please visit www.nychealthandhospitals.org/metropolitan.
Worldwide there are currently 3,021,049 coronavirus cases, 208,527 reported deaths, while 891,212 people have survived. In the US, there are currently 991,071 coronavirus cases, 55,879 reported deaths, while 120,122 people have survived. 
 
Today, Seattle-based Atossa Therapeutics (NASDAQ: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need, 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.
 
The NY HOPE Study is currently pending IRB approval and will not commence without IRB and all necessary regulatory approvals, including FDA. Atossa has filed comprehensive provisional patent applications related to AT-H201. 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.

“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. The NY HOPE Study is a vital step in developing this new therapy for critically ill COVID-19 patients,” stated Dr. Steven Quay, President and CEO of Atossa Therapeutics. 


ABOUT ATOSSA’S COVID-19 HOPE PROGRAM

Atossa’s COVID-19 program is called “COVID-19 HOPE,” which is an acronym for AT-H201 in COVID-19 patients for Pulmonary Evaluation. 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 combination can be developed more quickly than a traditional vaccine.

The NY HOPE Study is a critical step in determining the safety and efficacy of AT-H201 and in bringing this new therapy to the market.




ABOUT THE INVENTOR, DR. STEVEN QUAY

AT-H201 was invented by Dr. Steven Quay. Dr. Quay received his M.D., M.A., and Ph.D. from The University of Michigan was a postdoctoral fellow at MIT with Nobel Laureate H. Gobind Khorana, a resident at the Harvard-Massachusetts General Hospital, and was on the faculty of Stanford University School of Medicine for almost a decade. He has over 300 published contributions to medicine which have been cited over 9,700 times. Dr. Quay has founded six pharmaceutical companies, invented seven FDA-approved medicines, and holds 87 U.S. patents.

“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. 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” stated Dr. Steven Quay, Atossa’s President and CEO.

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.

ABOUT NYC HEALTH + HOSPITALS/METROPOLITAN

NYC Health + Hospitals/Metropolitan is the community hospital of choice for residents of East Harlem, northern Manhattan, and neighboring communities. NYC Health + Hospitals/Metropolitan provides culturally sensitive primary and specialized medical care to patients of all ages regardless of national origin, immigration status, or ability to pay. Since its founding in 1875, the hospital has been affiliated with New York Medical College, representing the oldest partnership between a hospital and a private medical school in the United States. NYC Health + Hospitals/Metropolitan is part of the NYC Health + Hospitals public health care system. For more information, please visit www.nychealthandhospitals.org/metropolitan.

SHARES OF ATOSSA THERAPEUTICS (ATOS)

Atossa’s shares have been on an upward trend lately after touching a low of $.76/share during the recent market selloff. Recently shares spiked to an intraday high of $3.11/ share. Currently today ATOS shares are trading at $2.23/share up +2.3% and have hit an intraday high of $2.47. I would expect the company to release more clarity and further updates on the progress of the trial opportunity in the near term as I would hope that it would be expedited trial during the COVID-19 crisis. 

ANALYST BUY RATING

Maxim Group’s Sell-side Biotech Analyst Jason McCarthy issued an update report today on Atossa Therapeutics, Inc. (NASDAQ: ATOS) titled “Expanding into the COVID-19 Therapeutics Race with a Differentiated Approach – Reiterate Buy.” He maintains a Buy Rating with a $4/share 12-month price target. View Maxim’s report here.

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