Aeolus Pharmaceuticals, Inc. is developing its lead compound, AEOL-10150, as a treatment for the pulmonary and delayed effects of acute radiation exposure (“Lung-ARS” and “DEARE”). The Company’s development work is funded under a five year, $118 million, cost-plus contract with the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the U.S. Department of Health and Human Services. BARDA is the Federal agency in charge of contracting for advanced development of drugs to treat radiological, biological and chemical threats for the civilian population. BARDA also manages the $2.8BB Special Reserve Fund for the purchase of these drugs for the U.S. Strategic National Stockpile.
Under the contract, Aeolus expects to meet the requirements for a pre-Emergency Use Authorization filing for AEOL-10150 in 2014. An Emergency Use Authorization (“EUA”) is a finding by the U.S. FDA that allows the use of unapproved drugs in the event of an emergency. BARDA has historically made the majority of its purchases for the stockpile using the EUA prior to FDA approval.
AEOL-10150 has demonstrated survival advantage in multiple animal models for Lung-ARS. The Company is currently conducting an efficacy study in non-human primates that will be complete in Q3 2014. Because of the nature of lethal radiation studies, no human efficacy studies are possible or required for FDA approval for Lung-ARS.
Aeolus also receives funding from the National Institutes of Health for the development of AEOL-10150 as a treatment for exposure to chemical gas (e.g., mustard and chlorine) and nerve agents (e.g., sarin and soman). The development work under these programs has positioned AEOl-10150 as a treatment for multiple biodefense threats, making it an attractive candidate for potential procurement into the Strategic National Stockpile.
AEOL-10150 has been tested in two Phase I human safety studies with no adverse events and no maximum tolerated dose.
Aeolus is leveraging the significant investment from the US Government to develop AEOL-10150 as a combination therapy for patients receiving radiation treatment for cancer. One million patients each year receive radiation therapy for solid tumors but the effectiveness of this treatment is often compromised by side effects that cut short treatment or limit the dose of therapeutic radiation delivered.