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Atossa Therapeutics Announces Successful In vitro Testing Results of COVID-19 Drug: AT-H201 Inhibits SARS-CoV-2 Infectivity of VERO Cells in Laboratory Culture

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Atossa Therapeutics (Nasdaq: ATOS) reported successful in vitro results for its COVID-19 drug candidate, AT-H201, demonstrating potent inhibition of SARS-CoV-2 infectivity in VERO cells. The study showed AT-H201 as the first submicromolar inhibitor identified, surpassing the potency of remdesivir by four times and hydroxychloroquine by twenty times. Dr. Steven Quay, CEO, expressed optimism for further clinical development. However, the company warns that these initial results do not guarantee success in human trials, with additional safety and efficacy studies necessary before commercialization.

Positive
  • Successful in vitro testing of AT-H201 for COVID-19 indicates strong antiviral properties.
  • AT-H201 identified as the first submicromolar inhibitor of SARS-CoV-2.
  • AT-H201 demonstrated at least four-times greater potency than remdesivir and twenty-times greater than hydroxychloroquine.
Negative
  • Initial in vitro results do not guarantee similar outcomes in human clinical trials.
  • Regulatory approvals and further safety studies are required before commercialization.

SEATTLE, May 20, 2020 (GLOBE NEWSWIRE) -- 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 the successful results from in vitro testing of AT-H201, Atossa’s proprietary COVID-19 drug candidate. The preliminary study results show that AT-H201 inhibits SARS-CoV-2 infectivity of VERO cells in a laboratory culture, which are the standard cell types being used to study infectivity of the coronavirus. SARS-CoV-2, sometimes called the coronavirus, is the COVID-19 infectious agent.  

AT-H201 is designed to act as a “chemical vaccine” by binding to the surface of the coronavirus and inhibiting the ability of the virus to enter a cell (“viral infectivity”). Significant findings from the testing include:

  • AT-H201 components inhibited SARS-CoV-2 from infecting VERO cells in a laboratory culture.
     
  • This is the first submicromolar inhibitor of SARS-CoV-2 identified to date in published literature, meaning that a relatively small amount of the drug is necessary to result in an anti-viral effect.
     
  • Testing was also performed on remdesivir, an anti-viral medication being studied by others for use in COVID-19 patients, and the generic anti-malaria drug hydroxychloroquine, which is also being studied by others in COVID-19 patients. In these laboratory tests, the components of AT-H201 were found to be at least four-times more potent than remdesivir and at least twenty-times more potent than hydroxychloroquine. Potency was measured by microscopic examination of the cytopathic effect caused by SARS-CoV-2 in VERO cells.

“These results support the continued development of AT-H201 for COVID-19 patients and beginning studies in the clinical setting,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “We look forward to reporting progress in clinical studies.”

The testing was conducted on behalf of Atossa by a leading academic research institute. Atossa plans to publish a manuscript of these test results. 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-H201 may be commercialized.

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-H201, 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.

FAQ

What are the results of Atossa Therapeutics' AT-H201 testing?

Atossa Therapeutics reported that AT-H201 showed significant inhibition of SARS-CoV-2 in laboratory tests, making it a promising COVID-19 treatment.

How does AT-H201 compare to remdesivir and hydroxychloroquine?

AT-H201 was found to be at least four times more potent than remdesivir and twenty times more potent than hydroxychloroquine in laboratory tests.

What is the next step for the development of AT-H201?

Atossa plans to advance AT-H201 into clinical studies following the successful in vitro results.

What are the risks associated with AT-H201’s development?

Risks include the uncertainty of translating in vitro results to in vivo studies and the need for regulatory approvals.

What is the significance of AT-H201 being a submicromolar inhibitor?

Being a submicromolar inhibitor means that AT-H201 requires a relatively small amount to effectively inhibit viral infectivity.

Atossa Therapeutics, Inc.

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