Novartis' Malaria Treatment Candidate To Move Forward With Phase 3 Development Next Year

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.