The objective of this contract is to determine the feasibility of a clofazimine inhalation formulation for preclinical development in tuberculosis

Multi drug resistant tuberculosisMDR TBis now estimated to be responsible fornew infections annuallyObservational studies have demonstrated the addition of clofazimine to MDR TB treatment regimens is an effective therapeutic strategy for clearing infections and improving patient outcomesHowevercurrent treatment regimens are longand prolonged systemic administration of clofazimine causes severe side effectsThe administration of aerosolized clofazimine would increase respiratory concentrationsreducing associated side effects and treatment timesWe hypothesize that treatment with aerosolized clofazimine will improve bacterial clearancereduce therapeutic timesand reduce treatment adverse effects in TB patientsQrumPharma has developed a clofazimine formulation for the treatment of NTM infectionsPreliminary studies have shown that this formulation is suitable for aerosolization via nebulizersThis development effort will be leveraged to generate a TB specific clofazimine product for inhalationdecreasing cost and time associated with developing a TB specific drug productIn Phaseof the programQrumPharma will investigate the efficacy of this formulation in vitro against drug susceptible and MDR XDR TB in planktonic and intracellular infection modelsQrumPharma will leverage studies currently underway to determine clofazimine safety and pharmacokinetics after aerosolized administrationFinallyQrumPharma will identify a nebulizer suitable for delivery of the formulation