Atossa Therapeutics Announces Advancement to Part B of Clinical Study of AT-H201
January 18 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 is advancing to enroll 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. 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.
Part A of the study, which consisted of a single ascending dose
group of 4 cohorts of healthy participants, has now been completed.
The Australian Human Research Ethics Committee has reviewed the
safety data from Part A and has approved the study to proceed to
Part B.“The results of the first part of the study were extremely
encouraging and the ethics committee concluded we may now proceed
to enroll the next group of participants,” said Steven Quay, M.D.,
Ph.D., Atossa’s CEO and President. “A record number of
hospitalizations driven by the Omicron variant is producing a
crisis at many healthcare facilities. Additional therapies to
combat COVID-19 are desperately needed.”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: 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. 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 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 than 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
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Sep 2023 to Sep 2024