ZYMERON CORPORATION — Department of Defense STTR Phase II: A18B-T022

Description

Oral malaria chemoprophylaxis is currently the US Army’s major intervention strategy in the prevention of malaria. However, it has been reported that compliance with the prescribed dosing regimen (i.e. daily oral tablets) by deployed service members is notoriously low (ranging from 30% to 56%) due to side effects, forgetfulness, and low perception of risk. An implantable long-acting chemoprophylaxis device with potency and safety better than or equal to the current standard of care would significantly reduce the logistic burden and eliminate medication noncompliance, and consequently improve the quality of preventative care for service members in malaria endemic regions. Zymeron developed a reservoir-based implantable drug delivery device (FilmDepot) to achieve long-term drug release and has demonstrated the technical feasibility of applying FilmDepot to develop long-lasting malaria chemoprophylactics. In the Phase II proposal, Zymeron will conduct a series of in vitro and in vivo evaluations for the safety, efficacy, PKPD and preclinical benefits. A scalable automated production process will be developed ready for GMP production and GLP studies.