Project Title: A randomized, open-label, multicenter study to compare efficacy, safety and tolerability of KLU156 with Coartem in the treatment of uncomplicated plasmodium falciparum malaria in adults and children 5kg body weight followed by an Extension phase with repeated KLU156 treatment
Project Description: All new malaria treatments should be developed as combinations of drugs with distinct mechanisms of action for synergistic or additive efficacy to mitigate the development of resistance and ensure cure. There is an unmet medical need for anti-malarial combination treatment including a partner drug with a new mechanism of action to counter the emergence of resistance to artemisinin. For this reason, ganaplacide has been combined with lumefantrine-SDF, which has an improved bioavailability and lower food... All new malaria treatments should be developed as combinations of drugs with distinct mechanisms of action for synergistic or additive efficacy to mitigate the development of resistance and ensure cure. There is an unmet medical need for anti-malarial combination treatment including a partner drug with a new mechanism of action to counter the emergence of resistance to artemisinin. For this reason, ganaplacide has been combined with lumefantrine-SDF, which has an improved bioavailability and lower food effect as compared to lumefantrine conventional formulation, thereby allowing a potentially curative once daily three-day regimen. This Phase 3 study includes a Core phase and an Extension phase. The Core phase of this study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for 3 days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection) in order to support marketing authorization application for KLU156. The Extension phase is designed to assess the safety, tolerability and efficacy of repeated treatment with KLU156 for a maximum of two years in patients who have completed the Core phase without experiencing early treatment failure (ETF) nor any study treatment-related SAE and who consent to participate in the Extension phase.
Principal Investigator : Ally Olotu
Department Name :
Time frame: (2024-03-27) - (2027-12-31)
NOVARTIS SOUTH AFRICA (PTY) LTD (Normal)
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