Aeolus Pharmaceuticals has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a phase I study of a radiation protection drug.
The new phase I trial is for the development of AEOL 10150 as a medical countermeasure for lung damage due to radiation exposure, the company said. Aeolus is developing the drug for this indication under a five-year contract valued at up to $118 million with the Biomedical Advanced Research and Development Authority (BARDA) in the U.S. Department of Health and Human Services.
AEOL 10150 was previously tested in 39 patients with amyotrophic lateral sclerosis (ALS) in two phase I safety studies, in which it was well-tolerated with no serious adverse events reported.
AEOL 10150 is a broad-spectrum catalytic antioxidant designed to neutralize reactive oxygen and nitrogen species, according to the company.
