Atossa Therapeutics Inc (NASDAQ: ATOS) announced that the company had received regulatory approval to open a clinical study of AT-H201 in Australia. Human Research Ethics Committee (HREC) granted the company permission to open up a clinical study of AT-H201 in Australia.
The company is developing the formula as inhalation therapy.
Atossa Therapeutics Inc is developing a nebulized formulation, AT-H201. The company is developing the formula as an inhalation therapy for moderately to severely ill hospitalized COVID-19 patients. In addition, long-haul patients and those with a post-infection pulmonary disease can also take advantage of the formula.
About the AT-H201 formula and its usage
AT-H201 is a combination of two drugs that are used to treat diseases and by other administration routes. The AT-H201 is an FDA-approved drug. When inhaled using a nebulizer, the drug can improve compromised lung function for moderate to severely ill, hospitalized COVID-19 patients and ‘long-haul’ patients with post-infection pulmonary disease.
It is not guaranteed that the respective study will be successful
The approval for usage of the AT-H201 will be granted after the Phase 1/2a study in Australia, and other clinical studies are completed. However, it is still not confident that the studies will be successful. It is unsure if regulatory approvals will be granted.
An official from Atossa Therapeutics Inc comments on the study
“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,” said Steven Quay, M.D., Ph.D., Atossa’s CEO, and President. “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.”