Atossa Therapeutics Announces Second COVID-19 Therapeutic Development Program, AT-301 Nasal Spray: Summit Biosciences Retaine...
May 28 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, announced that
it has begun the development of a second COVID-19 program using its
proprietary drug candidate AT-301, to be administered by nasal
spray.
AT-301 is Atossa’s proprietary formula intended for nasal
administration in patients immediately following diagnosis of
COVID-19 but who have not yet exhibited symptoms severe enough to
require hospitalization. It is intended for at-home use to
proactively reduce symptoms of COVID-19 and to slow the infection
rate so that a person’s immune system can more effectively fight
SARS-CoV-2 (coronavirus). Atossa also intends to conduct testing to
determine whether AT-301 can be used as a prophylaxis to prevent or
mitigate SARS-CoV-2, with the goal that it could become a “bridge
to the vaccine” and be useful in the next phase of the coronavirus
pandemic.
“In April we launched our AT-H201 COVID-19 HOPE program for the
most severely ill COVID-19 patients,” commented Steven Quay, M.D.,
Ph.D., President and CEO of Atossa. “By contrast, our new AT-301
nasal spray program is being developed for the relatively healthier
COVID-19 patients who have not been hospitalized. We are developing
AT-301 with a nasal spray delivery mechanism because many COVID-19
patients are infected via the nasal passage. The mechanism of
action is intended to inhibit essential human host proteases, which
are found in abundance in the nasal mucosa, from activating the
SARS-CoV-2 Spike Protein, the known first and obligatory step that
must be taken before the virus can enter the body.”
“This may eventually be useful as a prophylactic, to be used
before leaving the home. In that setting it would be intended to
create a barrier inside the nose to prevent virus entry - sort of a
short-term vaccine-like treatment that could be helpful before a
true vaccine is available. Our goal with the two COVID-19 programs
is to ultimately commercialize therapies for patients on both ends
of the spectrum – from the healthier patients who will be treated
at home and the sicker patients who require mechanical ventilation
in the hospital,” concluded Dr. Quay.
Atossa has retained Summit Biosciences, Inc., a pharmaceutical
company with a proven track record in nasal spray medicines, to
develop and produce a clinical supply of pre-filled nasal spray
products in multi-dose devices containing AT-301 with the goal of
commencing initial human clinical trials in the third quarter
2020.
Next steps with this program include the design and
manufacturing of the clinical trial materials and the active
pharmaceutical ingredients in AT-301 followed by adequate and
well-controlled studies to demonstrate safety and efficacy. These
studies must be successfully completed and regulatory approvals
must be obtained before AT-301 may be commercialized. Atossa has
filed provisional patent applications on AT-301 to treat patients
diagnosed with, or to prevent, COVID-19 via nasal spray and intends
to apply to the FDA as soon as possible so that human clinical
trials may be commenced in the third quarter 2020.
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.
About Summit Biosciences
Founded in 2009, Summit Biosciences, Inc. of Lexington, KY
(www.summitbiosciences.com) is a privately-held, specialized
pharmaceutical company focused on developing, manufacturing and
commercializing generic and innovative nasal spray medicines. It
collaborates on the development of products with its clients and
manufactures them at an industrial scale primarily for
commercialization in the US and Europe.
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 the following: 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 and the outcome of such trials, lower than anticipated rate
of patient enrollment, the safety and efficacy of Atossa’s product
candidates, performance of developers and manufacturers, clinical
research organizations and investigators, obstacles resulting from
proprietary rights held by others such as patent rights,
uncertainties affecting our ability to secure patent protection for
AT-301 or AT-H201 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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