Atossa Therapeutics Announces Availability of Manuscript on Results from In vitro Testing of COVID-19 Drug, AT-H201

Rhea-AI Summary

Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced promising in vitro test results for its COVID-19 drug candidate, AT-H201. The study indicates that AT-H201 significantly inhibits SARS-CoV-2 infectivity in VERO cells, showing it to be at least four times more potent than remdesivir and 20 times more potent than hydroxychloroquine. A provisional patent has been filed for AT-H201, although further safety and efficacy studies, as well as regulatory approvals, are required before commercialization.

Positive

• AT-H201 demonstrated superior potency against SARS-CoV-2, outperforming remdesivir by at least four times and hydroxychloroquine by at least 20 times.
• Provisional patent applications for AT-H201 have been filed, indicating a commitment to further development.

Negative

• Successful in vitro results do not guarantee in vivo efficacy or safety in human trials.
• Further regulatory approvals are required before AT-H201 can be commercialized, introducing uncertainty.

SEATTLE, June 11, 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, announced that the manuscript of the results from in vitro testing of AT-H201, Atossa’s proprietary COVID-19 drug candidate, titled: “AT-H201 constituents collectively are the most potent inhibitors of SARS-CoV-2 infectivity in VERO cells identified and mechanistically act as a chemical vaccine: Human safety data support rapid clinical development as inhaled therapy for COVID-19,” S. Quay, S. Chen, J. Rea and H. L. Remmel is now available at: ResearchGate Preprint AT-H201 laboratory testing against SARS-CoV-2.

The preliminary study results show that AT-H201 inhibits SARS-CoV-2 infectivity of VERO cells in a laboratory culture, which is a standard cell type being used to study infectivity of the coronavirus. Significant findings from the testing include:

• AT-H201 components inhibited SARS-CoV-2 from infecting VERO cells in a laboratory culture as measured by microscopy and SARS-CoV-2 N-protein immunostaining.

• AT-H201 appears to be the most potent inhibitor of SARS-CoV-2, defined as the ratio of the expected pulmonary dose to the in vitro effective dose, identified to date from published literature.

• 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. The AT-H201 components were found to be at least four times more potent than remdesivir and at least 20 times more potent than hydroxychloroquine. Potency was measured by microscopic examination of the cytopathic effect caused by SARS-CoV-2 in VERO cells.

The testing was conducted on behalf of Atossa by a leading academic research institute. Successful in vitro tests do not guarantee similar results in 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. Atossa has filed provisional patent applications on AT-H201 to treat COVID-19.

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 AT-H201 testing announced by Atossa on June 11, 2020?

The results indicated that AT-H201 significantly inhibits SARS-CoV-2 infectivity, proving to be more potent than existing treatments.

What is the status of AT-H201 regarding regulatory approval?

Regulatory approvals are still needed before AT-H201 can be commercially developed and used in human clinical trials.

How does AT-H201 compare to other COVID-19 treatments?

AT-H201 is reportedly at least four times more potent than remdesivir and 20 times more potent than hydroxychloroquine in laboratory testing.

What are the implications of the testing results for Atossa Therapeutics' future?

The results suggest potential for AT-H201 as an effective treatment, but further studies and approvals are necessary for market entry.