Type: Proprietary combination of two undisclosed “drugs that have been previously approved by the FDA to treat other diseases and by other administration routes,” 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.
AT-H201 is intended to be inhaled via a nebulizer to improve compromised lung function in moderately to severely-ill hospitalized COVID-19 patients as well as long-haul patients with post-infection pulmonary disease.
2021Status: Enrollment Begins in Long-Haul Trial—Atossa said September 30 that it had begun to enroll participants in a Phase I/IIa clinical study of AT-H201 in Australia. The placebo-controlled study is set to enroll a total of 60 healthy participants and moderately-ill hospitalized COVID-19 patients.
The study has 4 parts: a single ascending dose part, a multiple ascending dose part, a combination part in healthy individuals, and (subject to additional regulatory approval) a combination in COVID-19 infected patients. The study is being conducted by Australian clinical research organization Avance Clinical Pty Ltd.
2020 Status: Positive In Vitro Results–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.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: