The award will fund the continued development of promising medical countermeasures (MCMs) against nerve agents, including stable, fixed-dose combination formulations of atropine and scopolamine.
“This newly awarded grant will allow CMC Pharma to continue developing MCMs to protect our service members from nerve agents,” said Mike Dr. Radomsky said. “Previous SBIR grants have identified promising lead formulations, and this award gives us the opportunity to expand that research. We plan to conduct proof-of-concept non-clinical studies and chemistry, manufacturing, and administrative activities to further identify suitable cGMP drug manufacturing sites for materials required for IND readiness and clinical studies.”
CMC Pharma recognizes the current and future threats of chemical and biological warfare to combatants. The aim of this program is to develop a combination drug that is a stable and effective treatment for organophosphate nerve agent poisoning. Atropine and scopolamine combination formulations can enhance the therapeutic efficacy of current treatment regimens while minimizing the logistical burden associated with the execution and administration of multiagent MCM regimens.
This development effort bridges the gap between laboratory-scale innovation (ie, CMC Pharma’s previous efforts) and entry into the FDA-regulated pathway leading to commercialization. CMC Pharma plans to conduct future research to support FDA approval of the drug and to ensure a proper supply chain. In doing so, we have the vision to supply strategic national stockpiles with DoD-issued medicines to service members stationed in areas of potential nerve agent threat. .
CMC Pharma has successfully managed various drug development programs, including multi-year programs with the federal government. In addition, CMC Pharma has extensive experience with scopolamine and atropine formulations. Continued development of this new combination product will not only rely on existing expertise, but also the corporate strategy of providing drug development services to the Department of Defense to develop medical countermeasures to address threats to military personnel. help to move forward.
CMC Pharma has a portfolio of MCM products for chemical protection funded by DoD and is seeking partners to develop, manufacture and commercialize this portfolio of chemical protection MCMs.