Atossa Therapeutics Begins Enrollment in Clinical Study of AT-H201 in Australia
September 30 2021 - 9:30AM
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage
biopharmaceutical company seeking to discover and develop
innovative medicines in areas of significant unmet medical need in
oncology and infectious diseases with a current focus on breast
cancer and COVID-19, today announces it has begun to enroll
participants in its clinical study of AT-H201 in Australia. The
nebulized formulation, AT-H201, is being developed as an inhalation
therapy for moderately to severely-ill hospitalized COVID-19
patients and for “long-haul” patients with post-infection pulmonary
disease.
“Even with vaccines becoming widely available, the COVID-19
pandemic continues to be an urgent global health crisis,” said
Steven Quay, M.D., Ph.D., Atossa’s CEO and President. “Enrolling
the first two participants in this study marks a significant
milestone in our goal of ultimately developing nebulized AT-H201 to
improve lung function in patients with active disease, which may
reduce the number of patients requiring ventilators, and in
‘long-haul’ patients who have residual pulmonary function damage.
Up to one third of hospitalized patients have pulmonary function
changes 60 days or more after recovering from COVID. The
portability of nebulizers, already routinely used for other chronic
lung disease, should allow for treatment at home.”
The Phase 1/2a placebo-controlled study will enroll a total of
60 healthy participants and moderately-ill hospitalized COVID-19
patients. The study has 4 parts: a single ascending dose part, a
multiple ascending dose part, a combination part in healthy
individuals, and subject to additional regulatory approval a
combination in COVID-19 infected patients. The study is being
conducted by Avance Clinical Pty Ltd., a leading Australian
clinical research organization.
AT-H201 is a proprietary combination of two drugs
previously approved by the FDA to treat other diseases and by
other administration routes. AT-H201 is intended to be inhaled via
a nebulizer to improve compromised lung function for moderate to
severely ill, hospitalized COVID-19 patients and for “long-haul”
patients with post-infection pulmonary disease. In May 2020,
we completed in vitro testing of AT-H201 which showed that the
components of AT-H201 inhibit SARS-CoV-2 infectivity of VERO cells,
which is a standard cell type being used to study infectivity of
the coronavirus. The AT-H201 components were found to be at least
four times more potent than Remdesivir and at least 20 times more
potent than Hydroxychloroquine. Potency was measured by microscopic
examination of the cytopathic effect caused by SARS-CoV-2 in VERO
cells.
The Phase 1/2a study in Australia and other clinical studies
must be successfully completed and regulatory approvals must be
obtained before AT-H201 may be commercialized. No assurance can be
given that studies will be successful or that regulatory approvals
will be obtained.
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 in oncology and infectious
diseases with a current focus on breast cancer and COVID-19. For
more information, please
visit www.atossatherapeutics.com.
FORWARD-LOOKING STATEMENTS DISCLAIMER
STATEMENT
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,
without limitation, statements regarding the satisfaction of
closing conditions relating to the offering and the anticipated use
of proceeds from the offering, the risks and uncertainties
associated with any variation between interim 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 and continue studies of AT-H201, AT-301 and Endoxifen,
lower than anticipated rate of patient enrollment, estimated market
size of drugs under development, the safety and efficacy of
Atossa’s products, performance of clinical research organizations
and investigators, obstacles resulting from proprietary rights held
by others such as patent rights, whether reduction in Ki-67 or any
other result from a neoadjuvant study or reduction of breast
density will be approvable endpoints for oral Endoxifen, 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 Form 10-K and 10-Q, each as amended and
supplemented from time to time.
COMPANY CONTACT:Atossa Therapeutics, Inc.Kyle
Guse, CFO and General CounselOffice: (866)
893-4927kyle.guse@atossainc.com
INVESTOR RELATIONS CONTACT:Core IROffice: (516)
222-2560ir@atossainc.com
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