Atossa Therapeutics Announces Final Results from Phase 1 Clinical Study Showing Safety and Tolerability of AT-301 Nasal Spra...
February 25 2021 - 9:00AM
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage
biopharmaceutical company seeking to discover and 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 announced final results from its Phase 1
double-blinded, randomized, placebo-controlled clinical study using
Atossa’s proprietary drug candidate AT-301 administered by nasal
spray. AT-301 was considered to be safe and well tolerated in
healthy male and female participants in this study at two different
dose levels over 14 days. AT-301 is being developed for at home use
for patients recently diagnosed with COVID-19. There are currently
no FDA-approved therapies to treat COVID-19 at home.
Final analysis of the data from the study indicates that there
were no serious adverse events, no discontinuations, no
bronchospasms, and only one subject of the 32 subjects in the study
experienced adverse events that were considered moderate in
severity and all other adverse events were considered mild.
Atossa’s assessment is that AT-301 nasal spray was safe and well
tolerated in this study. The most common treatment-related adverse
events observed with AT-301 treatment with either single or
multiple doses were nasal discomfort and sneezing.
“The results from this study are very encouraging and we look
forward to quickly commencing the next study of AT-301,” commented
Steven Quay, M.D., Ph.D., Atossa’s President and CEO. “We recently
received input from the FDA on this program and based in part on
that input, we are now preparing to conduct an additional
pre-clinical study, which we expect to start this quarter.
Following that, we expect to apply to the FDA to commence a Phase 2
study here in the United States.”
Atossa also plans to develop its nasal spray to potentially help
prevent COVID-19 infection -- particularly for people in high-risk
environments, such as people living with an infected patient,
people living and working in healthcare facilities, emergency
responders or teachers.
Atossa believes that AT-301 nasal spray will play an important
role alongside the traditional vaccines now being deployed,
particularly as it becomes clear that it will take months or years
for vaccines to be administered around the world. New deadlier
and/or more infective variants of COVID-19 are being reported in
the U.S. and in many other countries and it is not clear that
current vaccines will be completely effective against these and
future variants. Additionally, none of the currently available
vaccines are 100% effective, they may have more significant side
effects in older people, and effectiveness is expected to diminish
over time. The intended mechanism of action of AT-301 is to prevent
virus entry into human cells by inhibiting the obligatory Spike
Protein activation. The activation is performed by three human cell
surface enzymes, ACE2, furin, and TMPRSS2, and is therefore
unaffected by mutations and variants in SARS-CoV-2.
The Phase 1 study was a double-blinded, randomized, and
placebo-controlled safety study of AT-301 nasal spray in 32 healthy
adult subjects who were 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 was a multiple dose arm with cohorts
receiving either AT-301A or AT-301B for 14 days at two different
doses. The primary objectives of the study were to evaluate the
safety and tolerability of single and multiple doses of AT-301
administered via nasal instillation to healthy volunteers.
Secondary objectives were to assess the incidence and severity of
local irritation and bronchospasm following administration of
AT-301 via nasal instillation. The study was 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 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 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 development plans, any
variation between interim, preliminary 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 CounselOffice: (866) 893-4927kyle.guse@atossainc.com
Investor Relations Contact:Core IROffice:(516)
222-2560ir@atossainc.com
Source: Atossa Therapeutics, Inc.
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