The U.S. Food and Drug Administration (FDA) recently granted fast track designation for Aeolus Pharmaceuticals’ treatment to prevent respiratory failure among patients at risk for radiation pneumonitis following a radiological incident which often leads to acute radiation syndrome (Lung-ARS).
Fast track designation allows for the expedited development and delivery of drugs that treat serious conditions and fill an unmet medical need. As a result of the designation, Aeolus’ treatment is now eligible for accelerated approval, priority review and rolling review from the FDA.
The treatment, AEOL 10150, was shown to protect tissue from damage in animal models after exposure to radiation and toxic chemicals. It also prevented additional trauma by mitigating, or in some cases stopping, cell death, while preventing inflammation and fibrosis through its action on oxidative stress and regulation of growth factors and chemokines.
According to Aeolus, AEOL 10150 performed well in preclinical and non-clinical studies, demonstrating statistically significant survival efficacy in an acute radiation-induced lung injury model. It was also found to be well-tolerated in two human clinical trials and is currently in the process of being tested in a new Phase 1 study among healthy subjects.
“We are pleased that the FDA has granted Fast Track designation to AEOL 10150 for the treatment of Lung-ARS following a radiological or nuclear event,” Aeolus President and CEO John McManus said. “There are currently no approved treatments for this syndrome and we are not aware of any other compounds in advanced development for this unmet need.”