Phase III Study for Novel Ganaplacide/Lumefantrine-SDF Combination in Adults, Children with Malaria Announced

Novartis and Medicines for Malaria Venture (MMV) have decided to progress ganaplacide/lumefantrine-solid dispersion formulation (SDF) into Phase III development for the treatment of patients with acute uncomplicated malaria due to plasmodium falciparum. This decision comes from the threat of resistance to current malaria treatment growth.

Ganaplacide is a novel agent combined with a new formulation of lumefantrine optimized for once-daily dosing, and it has the potential to clear malaria infection, like artemisinin-resistant strains, and to block the transmission of the malaria parasite.

Plasmodium falciparum malaria is primarily treated with artemisinin-based combination therapies (ACTs), like artemether-lumefantrine, and are still highly effective and well tolerated.

A Phase II, open-label, randomized controlled study was conducted in 524 adults and children with acute uncomplicated malaria due to plasmodium falciparum infection. Further, the ganaplacide/lumefantrine-SDF combination met the primary objective in both adults and children. The patients who received a once-daily dose of ganaplacide/lumefantrine-SDF throughout a three-day duration had a similar response to treatment to the rate observed in patients who received twice-daily artemether-lumefantrine control therapy during three days.

A large Phase III pivotal trial that is set to start in 2023 will compare the efficacy of ganaplacide/lumefantrine-SDF to the current “gold standard” artemether-lumefantrine.

“The emergence of artemisinin resistance demands urgent action to develop new antimalarials. 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 Sujata Vaidyanathan, MD, Head Global Health Development Unit, Novartis, in a press release. “The earlier we have new compounds and the faster the world adopts them, the better chance we stand of beating resistance.”

FDA granted Fast Track Designation and Orphan Drug Designation in August 2022 for the combination of ganaplacide and lumefantrine-SDF for the treatment of acute, uncomplicated malaria.

“We are increasingly seeing parasites with decreased sensitivity to artemisinin, even in Africa,” said Timothy Wells, MD, Chief Scientific Officer, MMV, in a press release. “If the Phase III trial is successful, this new combination will increase the number of options available to countries and help save the lives of children at risk of this devastating disease.”

Source: Novartis