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Novartis, MMV to advance new malaria therapy in phase 3 trial

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Novartis (NYSE:NVS) and Medicines for Malaria Venture (MMV) have decided to advance ganaplacide/lumefantrine- solid dispersion formulation (SDF) into phase 3 development to treat patients with acute uncomplicated malaria due to Plasmodium falciparum.

The Swiss pharma giant said that ganaplacide is a novel agent with a new mechanism of action and the combination also contains a new formulation of lumefantrine, which allows it to be given once daily versus the usual twice-daily administration.

Novartis added that the combination has the potential not only to clear malaria infection, including artemisinin-resistant strains, but also to block the transmission of the malaria parasite.

“We need non-artemisinin-based medicines with novel mechanisms of action against resistant parasites, and simple, easy-to-follow dosing schedules to help increase treatment adherence,” said Dr Sujata Vaidyanathan, head Global Health Development Unit, Novartis.

The drug is being developed with scientific and financial support from MMV and their partners.

The phase 3 study is planned to start in 2023 and will evaluate ganaplacide/lumefantrine-SDF to the current ‘gold standard’ artemether-lumefantrine, the company added.

Novartis said that the trial will be conducted in collaboration with the WANECAM 2 consortium, and will include partner clinical sites in Burkina Faso, Mali, Gabon and Niger and in sub-Saharan Africa.

The company noted that a phase 2 trial in 524 adults and children with acute uncomplicated malaria due to Plasmodium falciparum infection had met its main goal.

The ganaplacide/lumefantrine-SDF combo had received fast track and orphan drug designations in the U.S. in August to treat acute, uncomplicated malaria.

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