Atossa Therapeutics Contracts with NYC Health + Hospitals/Metropolitan for COVID-19 HOPE Clinical Study
April 27 2020 - 8:00AM
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.
“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.
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.
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 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.
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.
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
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