Atossa Therapeutics Announces Enrollment and Dosing Completed in First Group of Healthy Participants in Clinical Study of AT...
August 17 2020 - 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
with a current focus on breast cancer and COVID-19, today announced
that it has enrolled and dosed the first cohort of healthy
participants in the Phase 1 clinical study using its proprietary
drug candidate AT-301, being administered by nasal spray. This
group of 8 participants received a single dose of either AT-301A
(placebo) or AT-301B (active).
“Advancing our COVID-19 drug candidates through clinical studies
as quickly as possible is our highest priority,” commented Steven
Quay, M.D., Ph.D., Atossa’s President and CEO. “We are very
encouraged by the high level of interest in this study and the
speed at which we enrolled this first group of participants. Our
novel nasal spray drug candidate is being developed to provide a
unique protective mucosal barrier with anti-viral properties within
the nasal cavity, hopefully leading to lower infectivity and
reduced symptoms in COVID-19 patients. If this can slow virus
proliferation sufficiently to allow the patient to mount a strong,
natural immune response AT-301 could significantly impact the
current public health options for controlling COVID-19. We look
forward to quickly completing enrollment of all cohorts in this
potentially important study.”
The study is a double-blinded, randomized, and
placebo-controlled safety study of AT-301 nasal spray in 32 healthy
adult subjects divided into two study groups. Part A consists of
two single-dose cohorts receiving either active therapy, AT-301B,
or the placebo comparator AT-301A at two different doses. Part B is
a multiple dose arm with cohorts receiving either AT-301A or
AT-301B for 14 days at two different doses. The primary objective
of the study is to evaluate the safety and tolerability of single
and multiple doses of AT-301 administered via nasal instillation to
healthy volunteers. Secondary objectives are to assess the
incidence and severity of local irritation and bronchospasm
following administration of AT-301 via nasal instillation. The
study is being conducted in Australia.
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 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 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
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 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 is
an approvable endpoint 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 Counsel Office: 866 893-4927 kyle.guse@atossainc.com
Investor Relations Contact: Core IROffice:(516)
222-2560ir@atossainc.com
Source: Atossa Therapeutics, Inc.
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