Atossa Therapeutics Announces Completion of Part B of Clinical Study of AT-H201
April 20 2022 - 9:30AM
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage
biopharmaceutical company seeking to 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 completed enrolling participants
in Part B of its Phase 1/2a clinical study of AT-H201 in Australia,
consisting of multiple ascending dose cohorts in healthy
participants. 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.
“Part B of the study was successfully completed and, subject to
approval from the ethics committee, we will now proceed to enroll
the next group of participants,” said Steven Quay, M.D., Ph.D.,
Atossa’s CEO and President. “Despite widespread availability of
vaccines, many areas of the world are seeing a recent surge in
COVID-19 cases. There continues to be a strong need for additional
therapies to combat COVID-19.”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 four
parts: Part A - a single ascending dose part; Part B - a multiple
ascending dose part; Part C - a combination part in healthy
individuals; and Part D - a combination in COVID-19 infected
patients. Parts A, B and C of the study are being conducted by
Avance Clinical Pty Ltd., a leading Australian clinical research
organization. Commencing Parts C and D of the study is subject to
additional approvals from the Australian Human Research Ethics
Committee.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
nebulizer to improve compromised lung function for moderately 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, a standard cell type being used to study infectivity of the
coronavirus. 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
THERAPEUTICSAtossa Therapeutics, Inc. is a clinical-stage
biopharmaceutical company seeking to 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 STATEMENTForward-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.comINVESTOR
RELATIONS CONTACT:Core IROffice: (516)
222-2560ir@atossainc.com
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