The National Institutes of Health (NIH) Countermeasures Against Chemical Threats (CounterACT) program has released two new funding opportunities to support identification and optimization of therapeutics to treat exposures to chemical warfare agents and toxic industrial chemicals.
The civilian chemical threat spectrum includes chemical warfare agents (e.g., sarin), toxic industrial chemicals (e.g., cyanide), pesticides (e.g., parathion), and other chemicals.
NIH CounterACT cooperative agreement projects will support studies to generate the tools, efficacy in an appropriate animal model, and safety and pharmacology data necessary to transition the proposed therapeutics to advanced drug development, regulatory approval, and licensure.
Identification of Therapeutic Lead Compounds
Supports research on the identification of small molecule or biologic lead compounds that are excellent candidates for therapeutic development. Includes confirmation of molecular targets for therapeutic development, demonstration of in vitro activity of candidate therapeutics, preliminary in vivo proof-of-concept efficacy data, preliminary adsorption, distribution, metabolism, excretion, and toxicity (ADME/Tox) evaluations and pharmacokinetics/pharmacodynamics (PK/PD) data.
Optimization of Therapeutic Lead Compounds
The scope of research supported includes development of appropriate human-relevant animal models and generation of in vivo efficacy data consistent with the intended use of the product in humans. It also includes bioanalytical assay development and validation, laboratory-scale and scale-up manufacturing of the product, and non-GLP toxicity and pharmacology studies. A previously identified lead compound is required to be eligible for this funding opportunity.
Funding for this effort will only support the development of lead compounds that can be used to reduce mortality or serious morbidity during a chemical emergency. The primary focus is on post-exposure efficacy; compounds that are only effective if administered prior to the chemical insult (prophylaxis efficacy) will be of lowest priority.
Applicants are encouraged to collaborate with laboratories that are already certified and legally authorized to work with restricted chemical agents, such as the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) and certain contract research organizations, when applicable.