Inhaled Delivery of Clofazimine - A High Efficiency, Flow Independent, Targeted, Low Cost DPI

Multidrug resistance tuberculosisMDR TBis a global healthcare concern compounded by poor compliance associated with lengthy drug susceptible TBDS TBtreatment regimensClofazimineCFZis highly active against MDR TBbut oral use is limited by systemic toxicityhyperpigmentationGI effectsand QT prolongationInhalation of CFZ will overcome these limitations by achieving high local concentrations of drug and reducing systemic side effectsBased on our strong preliminary data we propose to develop a low costsimple to usealveolar macrophage targetedand efficient DPI that provides reproducible delivery regardless of inhalation forceOur specific aims areSADevelopment of a well defined formulation and delivery platform for the developed formulationSAConduct scale up batchespowder fillingbatch variabilitySAPreclinical in vivo testing in a validated small animal model and SAIND enabling toxicity studiesThe result will be a device drug combination system ready for submission of an IND and Phaseclinical testing in humansThe product will be optimized for cost efficient manufacturing and efficient lung delivery which will enable the company to pursue multiple therapeutic indications each with a viable commercial potentiale gMDR TBDS TBand NTM lung infections