Atossa Therapeutics said that the Human Research Ethics Committee (HREC) of the Australian National Health and Medical Research Council (NHMRC) has okayed a Phase 1/2a clinical study of the company’s nebulized AT-H201, which is “is a proprietary combination of two drugs previously approved by the FDA to treat other diseases and by other administration routes.” The company is developing AT-H201 for the treatment of moderate to severe COVID-19 in hospitalized patients and for the treatment of “long-haul” COVID-19.
Avance Clinical will conduct the SAD/MaD study, which is expected to enroll a total of 60 healthy volunteers and moderately-ill hospitalized COVID-19 patients. Earlier this year, Atossa announced positive results from a Phase 1 study of its AT-301 nasal spray, which it is developing as an at-home treatment for COVID-19.
Atossa President and CEO Steven Quay commented, “The COVID-19 pandemic continues to be an urgent health crisis with many regions reporting low vaccination rates combined with new SARS-CoV-2 variants proving more infectious and more deadly. If the initial parts of the study are successful, we will study the efficacy of our proprietary AT-H201 on moderately ill COVID-19 patients who can be treated via a nebulizer. Our goal in developing nebulized AT-H201 is to improve lung function in patients with active disease, which may reduce the number of patients requiring ventilators and in ‘long-haul’ patients who have residual pulmonary function damage. Up to one third of hospitalized patients have pulmonary function changes 60 days or more after recovering from COVID. The portability of nebulizers, already routinely used for other chronic lung disease, allows for treatment at home.”
Read the Atossa Therapeutics press release.
