Aeolus Pharmaceuticals Inc. announced that it has released its first lot of final drug product manufactured under new processes and with a new formulation. The manufacturing and formulation work was funded through its advanced research and development contract from the Biomedical Advanced Research and Development Authority (BARDA). The BARDA contract supports the development of AEOL 10150 as a medical countermeasure (MCM) for the lung sub-syndrome of Acute Radiation Syndrome (Lung ARS).

The five-year, cost-plus contract, valued with options at up to $118 million, includes funding for the development of large-scale, Good Manufacturing Practice production capacity for AEOL 10150. The new manufacturing process resulted in a 90% reduction in the production cost of the drug substance. Final refinement of the manufacturing processes and validation of methods will begin in February and is expected to be complete by the end of July 2014.

At that time, the company expects to be in a position to produce the bulk drug substance and final drug product lots required for the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Lung ARS and ultimately, for treatment of patients undergoing radiation therapy. Stability on the new formulation of final drug product has been performed under refrigerated, room temperature and accelerated conditions out to 18 months and will continue out to five years. Stability on the new bulk drug substance has been performed under refrigerated, room temperature and accelerated conditions out to 6 months.

This data builds on 24 month stability data for the bulk drug substance manufactured under the prior processes. Under the contract with BARDA, stability testing will be performed under refrigerated, room temperature and accelerated conditions on all bulk drug substance lots out to 36 months and on all final drug product lots out to 60 months. AEOL 10150 is a broad-spectrum catalytic antioxidant specifically designed to neutralize reactive oxygen and nitrogen species.

The neutralization of these species reduces oxidative stress, inflammation, and subsequent tissue damage-signaling cascades resulting from radiation exposure. AEOL 10150 has already performed well in animal safety studies, was well-tolerated in two human clinical trials, and has demonstrated statistically significant survival efficacy in multiple Lung-ARS studies in animals. AEOL 10150 is also currently in development for use as both a therapeutic and prophylactic drug in cancer patients.