Atossa Therapeutics Seeks Clinical Investigation Approval from FDA to Launch the COVID-19 HOPE Study
April 20 2020 - 8:00AM
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-H201in 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
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
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