Aeolus Pharmaceuticals, Inc. was founded as Intercardia, Inc (later, Incara Pharmaceuticals Corp.) in 1994. Until 2004, Incara was engaged in the development of non-antioxidant drug platforms. In 2003, the Company was renamed Aeolus Pharmaceuticals, Inc. and a new board and management was brought in to focus on developing a new class of metalloporphyrins for use as catalytic antioxidants to treat disease. These compounds were the result of research at Duke University in the lab of Dr. Irwin Fridovich and at National Jewish Medical Center in Colorado. At Duke, Dr. Fridovich identified the body’s natural antioxidant enzyme, superoxide dismutase or “SOD,” and his lab began to develop a portfolio of compounds that would mimic the mechanism of action of SOD, but at more powerful levels. This work was carried forward by Dr. Brian Day at National Jewish and resulted in the portfolio of metalloporphyrins being developed by Aeolus.
In 2003, the Company filed an IND for AEOL-10150 as a treatment for amyotrophic lateral sclerosis (“ALS” or “Lou Gehrig’s disease”) and completed two Phase I human safety trials. At the completion of the human safety trials, the Company began to evaluate the use of AEOL-10150 in combination with radiation therapy for cancer. Based on an evaluation of the clinical path to approval, Aeolus elected to pursue oncology in lieu of ALS trials. The IND for ALS is still open and the Company may elect to begin additional trials in this indication in the future. Aeolus’ business plan, however, is focused on the development of AEOL-10150 for use in oncology.
Based on promising data in mustard gas and chlorine gas from the laboratory of Dr. Carl White at National Jewish, the National Institutes of Health (“NIH’), through its Countermeasures Against Chemical Threats (“CounterACT”) program, began funding research into AEOL-10150 as an emergency medical countermeasure against chemical vesicants. After additional successful trials, Aeolus was invited by the Biomedical Advanced Research and Development Authority (BARDA), a part of the Department of Health and Human Services, to submit a proposal for a contract to develop AEOL-10150 through FDA approval and commercial scale manufacture as a medical countermeasure against chlorine gas exposure.