The Biomedical Advanced Research and Development Authority (BARDA) exercised $6 million in additional contract options under its advanced research and development contract with Aeolus Pharmaceuticals for AEOL-10150, a broad-spectrum catalytic antioxidant specifically designed to neutralize reactive oxygen and nitrogen species, as a treatment for the pulmonary syndrome of acute radiation syndrome (Lung-ARS) and delayed effects of acute radiation exposure (DEARE). The five-year contract was awarded in February of 2011 and is worth up to $118 million.
The options include funding for IND filing with the FDA for AEOL-10150 in Lung-ARS and DEARE, preparatory work for additional human clinical studies including PK/PD ADME and toxicity studies, additional murine efficacy trials including duration of treatment and delayed treatment studies, and continued development of large-scale, GMP manufacturing capability for AEOL-10150 project management costs. Aeolus expects revenue for fiscal year 2014 to exceed $9 million as a result of the exercise of the new options.
So far, through the end of August 2013, Aeolus has reportedly billed or completed approximately $16.1 million of programs under the contract and had committed work in progress totaling approximately $3.4 million.
"BARDA's exercise of additional options reflects the significant progress our team has made during the first two years of the Lung-ARS development contract," said John L. McManus, CEO and president of Aeolus, in a statement. "During this period, we delivered valuable animal models for Lung-ARS and made important progress in the manufacturing of AEOL 10150.... When combined with our ongoing studies in nonhuman primates and our completed work in GMP manufacturing development, these options will help Aeolus meet the requirements for a pre-EUA filing for AEOL-10150."
This is more good news for Aeolus, as last week NINDS awarded a $4.3 million grant to test the effects of AEOL-10150 against soman and other nerve agents. This grant was awarded to Manisha Patel, Ph.D., at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, who, along with fellow researchers, completed a pilot study demonstrating that AEOL-10150 provides neuroprotection, decreases oxidative stress, and significantly improves survival in rats exposed to pilocarpine, a surrogate for the nerve agents soman and sarin gas.