Challenge
The Department of Defense developed a new nerve agent antidote that will be critical to the survival of service members who are exposed to these threats on the battlefield. The unique properties of the drug’s toxicity levels limited the ability to test the compound in humans, which was delaying regulatory advancement. As a result, Battelle was tasked with performing preclinical safety studies to determine cause of toxicity in preclinical models in order to limit the Cmax and AUC exposure in humans.
Solution
Battelle evaluated the human data and determined that while AUC levels were being exceeded, the Cmax was not. Our researchers designed a series of novel studies to demonstrate that toxicity was linked to the Cmax, but not the AUC. The studies determined the cause of the toxicity and recommended a treatment for human exposure.
Impact
Based on the Battelle data and recommendations, the FDA allowed the completion of a pivotal human safety study. The Department of Defense is now investigating the possibility of obtaining an emergency use authorization for this compound.