Dosing Completed in Part C of Atossa’s Phase 1/2a Study of AT-H201 in Healthy Volunteers
28 July 2022 - 11:00PM
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 dosing participants in
Part C of its Phase 1/2a clinical study of its proprietary
inhalation therapy (or, AT-H201) in Australia.
AT-H201 consists of two drugs previously approved by the FDA to
treat other diseases. AT-H201 is intended to be inhaled via
nebulizer with the goal of preventing or reducing lung injury that
may be caused by fibrin deposition, fluid build-up and secondary
infection.
Part C of the study involved administering the two drugs in
succession in healthy volunteers. The study originally included a
Part D which was designed to assess the effects of the treatment
regimen in hospitalized COVID-19 patients with moderate illness.
However, due to the rapidly shifting COVID-19 treatment landscape
and the introduction of effective vaccines limiting
hospitalizations, Atossa has evaluated indications for AT-H201
beyond COVID-19 patients, including treating and/or preventing lung
injury in patients undergoing certain cancer treatments.
Rather than conducting Part D of the Phase 1/2a clinical study,
Atossa now plans to shift the development of AT-H201 to closely
align with its oncology focus by continuing the development in
patients with compromised lung-function due to the damaging effects
of cancer treatment. For example, radiation treatment can lead to
radiation induced lung injury, which is poorly treated with current
therapies and is often irreversible. Furthermore, radiation damage
can limit the overall success of lung cancer treatment leading to a
reduction in efficacy and poor disease control. AT-H201 has
pharmacological properties to potentially curtail excessive
radiation-induced lung injury without compromising standard of care
cancer therapy for cancer patients. AT-H201 is designed to prevent
and reduce dose-limiting toxicities, and enable a more durable
therapeutic tumor response for cancer patients receiving pulmonary
radiation.
“We are happy to have completed Parts A, B and C of the clinical
trial and look forward to evaluating the results,” said Steven
Quay, M.D., Ph.D., CEO and President of Atossa. “With widespread
availability of SARS-CoV-2 vaccines and other therapies now
approved to treat COVID-19, we believe that altering the
development pathways for AT-H201 in patients with compromised
lung-function resulting from radiation may fill a compelling unmet
medical need and create more value for our stockholders.“ Based on
our work to date with AT-H201, we believe we can quickly initiate a
clinical study in this setting and we plan to announce our next
steps in the fourth quarter,” concluded Dr. Quay.
Radiation Induced Lung Injury (RILI)
RILI is damage to the lungs caused by ionizing radiation
administered to treat cancer. RILI is a significant issue for
patients undergoing radiation treatment for various forms of cancer
and is often irreversible. For instance, RILI affects 30-40% of
lung cancer patients, and ~35% of esophageal cancer patients. In
non-small cell cancer patients receiving concurrent chemotherapy
and radiation therapy the incidence of RILI is estimated to be
greater than 60%. Although Atossa has not finalized the protocol
for this new trial we believe RILI affects a significant number of
patients across multiple cancer types and there is a meaningful
need for new treatments.
About AT-H201
AT-H201 is a proprietary sequential dosing regimen of two
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.
The Phase 1/2a study in Australia and other clinical studies
must be successfully completed and regulatory approvals must be
obtained before AT-H201 can be commercialized. No assurance can be
given that the 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 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
Forward-looking statements in this press release, which Atossa
undertakes no obligation to update, are subject to risk 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 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 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.Charles ButlerVice President, Investor and Public
Relationscharles.butler@atossainc.com
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