DTRA solicits proposals for nerve agent prophylaxis

The Defense Threat Reduction Agency announced on Wednesday that it is soliciting proposals for rapid innovation for intra-muscular delivery of reconstituted human plasma Butylcholine Esterase as prophylaxis against all classes of nerve agents.
The Department of Defense sponsors the development of intravenous administered hBuChE for prophylaxis against nerve agents, though the IV method has major limitations related to storage requirements and fast administration.
Current technology may allow for the lyophilization and reconstitution method to afford a higher concentration, which will solve the administration problem. IM therapeutics could also supplement or replace IV infusion. The lyophilized hBuChE preparation would be more easily stored and could benefit from the extended shelf life in the field. It could then be rapidly reconstituted on demand and be administered using an IM method.
While the technology required for lyophilization has developed significantly in prior research, the development of proper formulation is still required to be able to submit the method as an investigational new drug to be put into Phase I clinical trials and to apply for a U.S. Food and Drug Administration License. The DTRA is seeking proposals that will deliver the target product profile defined by the Joint Requirements Office for Chemical and Biological Defense over the course of 24 to 30 months.
The end goal is to produce a reconstituted hBuChE formulation that is concentrated at least four times more than current capacity, leading to the submission of an IND and the beginning of Phase I clinical trials targeting safety and pharmacokinetic parameters.