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Chemxpert database is a techno-commercial information platform developed and operated by Lifescience Intellipedia Pvt. Ltd. Our data provides valuable insights regarding sourcing, marketing, development, and regulatory functions for the entire Lifescience industry. The different industries covered by our data encompass APIs, FDFs, pharma intermediates, paints, dyes, polymers, biotechnology, biochemical, food additives, nutraceuticals, etc.

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24 Nov 2022
Admin
News Article

Novartis, MMV announce decision to move to phase 3 study for novel ganaplacide/lumefantrine-SDF combination in adults and children with malaria

As the threat of resistance to current malaria treatments grows, Novartis and Medicines for Malaria Venture (MMV) announce the decision to progress ganaplacide/lumefantrine- solid dispersion formulation (SDF) into phase 3 development for the treatment of patients with acute uncomplicated malaria due to Plasmodium falciparum. Ganaplacide is a novel agent with a new mechanism of action, which is combined with a new formulation of lumefantrine optimized for once-daily dosing. This combination has the potential not only to clear malaria infection, including artemisinin-resistant strains, but also to block the transmission of the malaria parasite. The medicine is being developed with scientific and financial support from MMV and their partners. As previously announced, a phase 2 open-label, randomized controlled study was conducted in 524 adults and children with acute uncomplicated malaria due to Plasmodium falciparum infection. The ganaplacide/lumefantrine-SDF combination met the primary objective in both adults and children. In patients who received a once-daily dose of ganaplacide/lumefantrine-SDF during 3 days, response to treatment was similar to the rate observed in patients who received twice-daily artemether-lumefantrine control therapy during 3 days. Planned to start in 2023, one large phase 3 pivotal trial will compare the efficacy of ganaplacide/lumefantrine-SDF to the current

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