- Novartis AG NVS and Medicines for Malaria Venture (MMV) have decided to progress ganaplacide/lumefantrine- solid dispersion formulation (SDF) into Phase 3 development for the treatment of patients with acute uncomplicated malaria.
- Ganaplacide is a novel agent with a new mechanism of action 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 its partners.
- In the Phase 2 trial, in patients who received a once-daily dose of ganaplacide/lumefantrine-SDF for three days, response to treatment was similar to the rate observed in patients who received twice-daily artemether-lumefantrine control therapy during three days.
- The trial is planned to start in 2023 and will compare the efficacy of ganaplacide/lumefantrine-SDF to the current gold standard artemether-lumefantrine.
- In June, Novartis pledged $250 million to R&D for new treatments of neglected tropical diseases (NTD) and malaria, intending to eliminate these diseases.
- In August 2022, the FDA granted Fast Track Designation and Orphan Drug Designation for the ganaplacide + lumefantrine-SDF combo for acute, uncomplicated malaria.
- Price Action: NVS shares are down 0.78% at $87.02 on the last check Wednesday.
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