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

Description

Oral 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. This poor compliance was a major contributing factor of the failure to prevent malaria infection in recent US military deployment to Northern Africa. 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. There are several FDA-approved implantable devices performing as long-acting drug delivery systems, however they have low drug loading, unable to sustain multi-month long releasing of malaria chemoprophylactic drugs that require very high doses (100 mg/day or higher). Zymeron proposes to develop a novel implant that elutes drugs at a constant rate for many months up to one year and the implant has extremely high loading of various drugs.