2022-11-23 15:36:55

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

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Benzinga
By Vandana Singh
  • Novartis AGNVS andMedicines for Malaria Venture(MMV) havedecidedto 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 toeliminate 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.

2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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