SBIR-STTR Award

Multi drug resistant tuberculosis MDR TBis now estimated to be responsible for new infections annually Observational studies have demonstrated the addition of clofazimine to MDR TB treatment regimens is an effective therapeutic strategy for clearing infections and improving patient outcomes However current treatment regimens are long and prolonged systemic administration of clofazimine causes severe side effects The administration of aerosolized clofazimine would increase respiratory concentrations reducing associated side effects and treatment time sWe hypothesize that treatment with aerosolized clofazimine will improve bacterial clearance reduce therapeutic times and reduce treatment adverse effects in TB patients Qrum Pharma has developed a clofazimine formulation for the treatment of NTM infections Preliminary studies have shown that this formulation is suitable for aerosolization via nebulizers This development effort will be leveraged to generate a TB specific clofazimine product for inhalation decreasing cost and time associated with developing a TB specific drug product In Phase of the program Qrum Pharma will investigate the efficacy of this formulation in vitro against drug susceptible and MDR XDR TB in planktonic and intracellular infection models Qrum Pharma will leverage studies currently underway to determine clofazimine safety and pharmacokinetics after aerosolized administration Finally Qrum Pharma will identify a nebulizer suitable for delivery of the formulation