Atossa Therapeutics Inc (ATOS)

[XenaLives]

Candidate: AT-H201

Type: Combination of two undisclosed “drugs that have been previously approved by the FDA for other diseases,” designed to act in the manner of a mucosal vaccine by binding to the surface of SARS-CoV-2 and blocking viral entry gene proteins in nasal epithelial cells. The chemical vaccine is designed to interfere with spike protein activation by host proteases, to mask receptor binding domains (RBD) via electrostatic mechanisms, and to provide a generalized mucoadhesive epithelial barrier.

Status: Atossa on June 11 announced positive results from in vitro testing of AT-H201 showing that it inhibited SARS-CoV-2 infectivity of VERO cells in a laboratory culture, as measured by microscopy and SARS-CoV-2 N-protein immunostaining. AT-H201 components were found to be at least four times more potent than Gilead Sciences’ Veklury™ (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.

In May, Atossa announced positive in vitro test results showing AT-H201 inhibited SARS-CoV-2 infectivity of VERO cells in a laboratory culture. AT-H201 is the first submicromolar inhibitor of SARS-CoV-2 identified to date in published literature, according to the company.

The components of AT-H201 were found to be at least four times more potent than Gilead Sciences’ remdesivir, and at least 20 times more potent than generic hydroxychloroquine, Atossa said. 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,” stated Steven Quay, MD, PhD, Atossa’s President and CEO.

In April, Atossa said it contracted with NYC Health + Hospitals/Metropolitan in New York City to conduct the NY HOPE Study, designed to assess AT-H201 administered via inhalation in COVID-19 patients on ventilators, with the goal of reducing the amount of time on ventilators. The company has applied for FDA approval for NY HOPE under the Coronavirus Treatment Acceleration Program.

In the study, 39 patients will be enrolled in the active treatment group and compared to the outcomes of 66 patients in a matched retrospective control group. Patients will be dosed with AT-H201 each day in addition to standard of care, while on mechanical ventilation for up to seven days, and will be followed up during hospitalization and for 28 days after discharge. Atossa said the primary objectives are to determine the number of ventilator-free days after patients are removed from ventilators following the initial airway intervention; oxygenation levels; and survival rates. Secondary efficacy endpoints include a variety of lung function parameters and time in ICU. Secondary safety endpoints include markers of coagulation and system function.

Atossa announced the drug development program April 16. The company has filed provisional patent applications with the U.S. Patent and Trademark Office directed to the formulation, manufacturing, and methods of use of AT-H201.

https://www.genengnews.com/covid-19-candidates/covid-19-too-soon-to-tell/atossa-therapeutics/

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

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.

https://atossatherapeutics.com/atossa-therapeutics-announces-availability-of-manuscript-on-results-from-in-vitro-testing-of-covid-19-drug-at-h201/