Atossa Therapeutics Receives Second Positive Interim Safety Assessment in Clinical Study of AT-301 Nasal Spray Being Develope...
September 17 2020 - 8:30AM
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
a positive interim safety assessment from the second cohort of
healthy participants in the Phase 1 clinical study using Atossa’s
proprietary drug candidate AT-301 administered by nasal spray. This
second group of eight participants received a single escalated dose
of either AT-301A (placebo) or AT-301B (active drug). The blinded,
positive assessment by the safety committee allows the study to now
enroll the next cohort, which will be the third of a total of four
cohorts and the first of two multi-dose, placebo controlled
cohorts.
“This second favorable safety review marks an important
milestone in this study as half the participants have now been
dosed and initial safety reviews have been successfully completed,”
commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO.
“Based on rapid enrollment in the first half of the study, we
expect to complete enrollment in the remainder of the study very
quickly. Recent data from the CDC suggests that more than 90% of
people testing positive for COVID-19 do not require
hospitalization. With this in mind, we are developing our AT-301
nasal spray for home-use because there are no currently
FDA-approved treatments to help these patients with early disease
to recover faster.”
Significant advances have been made in the field of COVID-19
diagnostic testing. These tests are now much more widely available
and they can render results much more quickly. Atossa plans to
identify potential partners who are developing these tests so that
AT-301 nasal spray may be co-developed and commercialized with the
goal of making the AT-301 therapy available at the time a person
tests positive for the coronavirus. Atossa also plans to develop
its nasal spray to potentially help prevent COVID-19 infection,
particularly for people in high risk communities and those working
in higher-risk areas, including healthcare workers, emergency
responders and teachers.
“We anticipate that our AT-301 nasal spray will complement any
traditional COVID-19 vaccine that may be developed,” added Dr.
Quay. “A traditional COVID-19 vaccine may be effective in in as few
as half of the people taking it and recent surveys indicate that as
many as one-third of Americans may choose not to take any COVID-19
vaccine once one becomes available. In addition, studies of
re-infection with the coronavirus suggest that the durability of
immunity, whether from an actual infection or a vaccine, may not be
ideal. As a result, therapies such as our nasal spray, similar to
therapies working in tandem with vaccines for seasonal flu, may
form an important part of a broader response to the coronavirus
pandemic.”
The ongoing Phase 1 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. (Nasdaq: ATOS) 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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