Battelle and CMC Pharmaceuticals are advancing a five-year, $40 million program to develop a medical countermeasure for nerve agent exposure under an agreement with the U.S. Department of War.
The Acetylcholinesterase Reactivator Development and Approval Pipeline, known as ARDAP, aims to move a drug candidate toward submission of an Investigational New Drug application to the Food and Drug Administration. The award was made through the Defense Threat Reduction Agency’s Joint Science and Technology Office.
The program focuses on an acetylcholinesterase, or AChE, reactivator intended to protect military personnel exposed to nerve agents. Its broader objective is to establish a development and approval pathway for improved treatments that could eventually be deployed in the field.
CMC Pharmaceuticals, based in Solon, Ohio, is handling chemistry, manufacturing and controls work. Its responsibilities include laboratory development, testing under current good manufacturing practices, formulation and manufacturing process development, stability evaluation and oversight of contract manufacturers. These activities support product development and regulatory submissions.
Battelle, CMC Pharmaceuticals and other program partners have advanced manufacturing, nonclinical and regulatory planning activities, alongside planning for clinical evaluation, according to the announcement. The release did not identify the drug candidate or provide a timetable for submitting the application or beginning clinical testing.
Drew Cawthon, Battelle’s business line director, said the organization was continuing its work on medical countermeasures for chemical threats as the program progresses toward an FDA submission.
CMC Pharmaceuticals President Mike Radomsky said the project adds to the company’s existing work on therapeutics and medical countermeasures for the federal government.
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