Atossa Therapeutics Announces Successful In Vitro Testing of Nasal Spray Formulation: AT-301 Inhibits SARS-CoV-2 Infectivity ...
15 July 2020 - 11:30PM
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
successful results from in vitro testing of AT-301,
Atossa’s proprietary COVID-19 nasal spray drug candidate. The
preliminary study results show that AT-301 inhibits SARS-CoV-2
infectivity of VERO cells in a laboratory culture, which is the
standard disease model used for initial screening of COVID-19 drug
candidates.
AT-301 is being developed with a nasal spray delivery mechanism
because many COVID-19 patients are infected via the nasal
passage. Collectively, the components of AT-301 are believed
to help maintain a protective mucosal like layer within the nasal
cavity with both anti-viral properties and protective mucosal like
barrier that may lead to lower infectivity and reduced symptoms in
COVID-19 patients due to their interference with the spike protein
of the virus in the nasal cavity and upper respiratory tract.
Atossa’s nasal spray formulation AT-301 is being designed to
contain ingredients that can potentially block SARS-CoV-2 viral
entry gene proteins in nasal epithelial cells by interfering with
spike protein activation by host proteases, by masking receptor
binding domains (RBD) via electrostatic mechanisms, and by
providing a generalized mucoadhesive epithelial barrier. “The
AT-301 formulation was designed to work like a mucosal vaccine,
blocking entry of the virus into the cells to begin with and thus,
hopefully, preventing a COVID-19 infection,” said Dr. Steven Quay,
Atossa’s President and Chief Executive Officer. “With the finding
that a particular cell found in the nasal cavity -- the goblet cell
-- has among the highest expressions of viral entry genes1, the
concept of targeting the nasal cavity to block early SARS-CoV-2
infection made a lot of sense. And having invented two FDA-approved
nasal spray products before founding Atossa, I am gratified to be
able to bring this prior clinical and regulatory experience to bear
on this devastating pandemic. We look forward to commencing a Phase
1 clinical study this quarter and reporting progress on this
clinical development program.” The purpose of these experiments was
to mimic the virus’s entry process in vitro by examining the
infectivity of VERO monkey kidney cells by authentic SARS-CoV-2
virus particles. Although VERO cells are non-mucosal epithelial
cells and therefore are more sensitive to cytotoxicity than would
be expected of mucosal cells, they provide an established COVID-19
disease model system to judge in vitro efficacy. Serial dilutions
of the AT-301 formulation were performed from 1 to 4 to 1 to 4096.
SARS-CoV-2 was incubated in these serial dilutions for 1 hour at
37° C and then the mixture was added to the cells for one hour at
37° C. The mixture was then removed and fresh media added at 37° C
and incubated overnight. The cells were then fixed with 10%
formalin overnight and then the cells were permeabolized with 0.5%
Triton X-100. H anti-SARS-2 N protein, 1 µg/mL, was added at room
temperature for 1 hour. Anti-human-IgG-488 (green) tagged antibody
was added at a 1:1000 dilution at room temperature for 1 hour. This
allowed visualization of the production of the N protein inside
cells as a green signal, the evidence that an infection had
occurred. The experiments show that serial dilutions of the AT-301
nasal formulation, beginning with a 1 to 4 dilution and going to a
1 to 16 dilution were able to prevent N protein expression.
Beginning at a 1 to 32 dilution the virus was able to infect the
cells. There was minimal toxicity noted. The in vitro laboratory
testing was conducted under contract at a leading academic research
center that specializes in infectious disease research.
Successful in vitro tests do not guarantee similar
results from in vivo studies, including in human clinical
trials. Additional safety and efficacy studies must be successfully
completed and regulatory approvals must be obtained before AT-301
may be commercialized. Atossa has filed provisional patent
applications with the U.S. Patent and Trademark Office directed to
the formulation, manufacturing, and methods of use of AT-301.
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, whether in
vitro test results will also be achieved in in
vivo studies, including human clinical studies, actions by and
interactions with the FDA, the outcome or timing of regulatory
approvals needed by Atossa including those needed to commence human
clinical studies of AT-301, 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, 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
IR Office: (516) 222-2560 ir@atossainc.com Source: Atossa
Therapeutics, Inc.
_________________________________________________
1 SARS-CoV-2 entry factors are highly expressed in nasal
epithelial cells together with innate immune genes
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Apr 2024 to May 2024
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From May 2023 to May 2024