Biotech company AVM Biotechnology LLC reported on Wednesday the receipt of approval from the US FDA to begin the clinical trials to evaluate its AVM0703 in the treatment of Acute Respiratory Distress Syndrome (ARDS) mediated by COVID-19 or Influenza patients.

This is the company's second safe to proceed clinical trial approval from the FDA within the past six months and the second study consists of two different ARDS patient populations: COVID-19-mediated moderate to severe ARDS and the with Influenza-mediated severe ARDS.

The company said that AVM0703 is a novel and proprietary formulation of high concentration of dexamethasone. The acute high or suprapharmacologic dose of AVM0703 mobilizes highly active Natural Killer T- (NKT) and cytotoxic T- cells and dendritic cells.

Within six hours of a single administration, AVM0703 kick-starts additional NKT cell activation, which is directly relevant to COVID-19- and Influenza-mediated ARDS because NKT cells are programmed to eliminate abnormal cells, whether cancer or virus-infected.

In conjunction, the rapid elimination of infected monocytes in COVID-19 patients could reduce ICU stays and decrease long-term lung damage. NKT mobilization could also provide long-term T-cell immunity, concluded the company.