Aeolus is developing a platform of novel compounds for use in biodefense, fibrosis, oncology, infectious disease and diseases of the central nervous system.
Our first compound, AEOL 10150 is being developed as a medical countermeasure against the pulmonary effects of Acute Radiation Syndrome (“Lung-ARS”) and the delayed effects of acute radiation exposure (“DEARE”) under a contract with the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the United States Department of Health and Human Services (“HHS”). The total value of the contract with all options is $118.4 million of which over $30 million has been expended to date.
The goal of the BARDA contract is FDA approval for AEOL 10150 as a treatment for Lung-ARS and DEARE. Prior to FDA approval, however, the contract requires Aeolus to file a pre-Emergency Use Authorization (“EUA”) application with the FDA. An EUA allows the use of unapproved drugs in cases of declared emergency. To date, BARDA has made the majority of its purchases for the Strategic National Stockpile following the filing of a pre-Emergency Use Authorization application.
The development work funded under the BARDA contract also supports part of the development costs for AEOL 10150 as a treatment for idiopathic pulmonary fibrosis (“IPF”). This development program was created based upon lung protection data generated from animal studies in Lung-ARS and chemical gas lung exposure under the BARDA contract and a company-funded study in the bleomycin lung fibrosis model. IPF is a chronic, progressive disease of the lungs characterized by increasing scarring (fibrosis) of the lung tissue. Median survival after diagnosis is 3 to 4 years and there is no cure.
The development work funded under the BARDA contract also supports part of the development costs for AEOL-10150 as a treatment for the side effects of radiation therapy for oncology. We plan to leverage the U.S. government investment to develop AEOL-10150 concurrently for use in an oncology setting.
Aeolus also receives grant funding from the National Institutes of Health (“NIH”) CounterACT program for development of the AEOL 10150 as a medical countermeasure against exposure to chemical gas and nerve agents. Multiple animal studies in exposure to sulfur mustard and chlorine gas have demonstrated a significant survival advantage following administration of AEOL 10150. Pilot studies in nerve gas exposure models have also demonstrated a survival advantage with AEOL 10150 when added to current standard of care.
AEOL 10150 has been tested in two Phase I clinical trials with no serious adverse events reported. Data have already been published showing that AEOL 10150 does not interfere with the therapeutic benefit of radiation therapy in prostate and lung cancer preclinical studies.
The Company also has two pre-clinical development programs.
AEOL 11114 was developed from our library of compounds through a research program funded by the Michael J Fox Foundation for Parkinson’s disease. Pre-clinical studies in mouse and rat models have demonstrated neuro-protective activity of AEOL 11114. We are currently conducting IND-enabling work and plan to file an IND for AEOL 11114 in 2017.
AEOL 20415 was developed in collaboration with National Jewish Health for the treatment of infectious diseases. The compound incorporates our platform technology into a novel approach to anti-microbial therapy. We are currently conducting IND-enabling work and plan to file an IND for AEOL 20415 in 2017. In addition, we plan to pursue potential U.S. government funding for the development of AEOL 20415 in the treatment of several biodefense threats.