Data from two relevant animal models were presented at the June 2017 CounterACT meeting hosted by Brigham and Women’s Hospital and Harvard Medical School in Boston. Mr. Basinger, Countervail’s CEO, presented a comparison of pharmacokinetics, pharmacodynamics and efficacy data on the guinea pig and non-human primate models for Countervail’s oral pre-treatment application of AverTox® (galantamine hydrobromide). In both of these relative models, AverTox pre-treatment significantly improved survival from supra-lethal nerve agent (i.e., soman) exposure better than the use of conventional care antidotes alone. Human Equivalent Dose (HED) was clinically relevant and fell within the FDA’s approved dose range as safe for human use. In both animal models, the efficacious dose fell below the No Observed Adverse Effects Level (NOAEL). Pharmacokinetics of galantamine demonstrated first order kinetics in both animal models as is seen in humans with linear relationships between dose and plasma drug concentration.
At present, first responder organizations and security personnel do not have access to any pre-treatment medical countermeasure for protection against nerve agent or OP pesticide exposure. Emergency Response Medical Directors agree that availability of a pre-treatment for first responders and security personnel will fill a needed void in improving the country’s preparedness against a nerve agent attack. Countervail’s pre-treatment application of AverTox will fill this void and make a material contribution to the country’s preparedness against these types of toxic exposures.