Ganaplacide/lumefantrinein new study as world faces emerging resistance to malaria treatments

Novartis and Medicines for Malaria Venture MMV have announced that they are to progress the ganaplacide/lumefantrine solid dispersion formulation (SDF) into phase 3 development.

The treatment involves patients with acute uncomplicated malaria due to plasmodium falciparum and is a response to increased concern over resistance to existing therapies.

Ganaplacide is a novel agent with a new mechanism, which is combined with a once-daily formulation of lumefantrine. This combination has the potential to clear malaria infection – including artemisinin-resistant strains – while also blocking transmission of the parasite. Currently, the medicine is being developed with scientific and financial support from MMV and their partners.

Due to start in 2023, one large phase 3 pivotal trial will compare the efficacy of ganaplacide/lumefantrine-SDF to the current ‘gold standard’ artemether-lumefantrine therapy. 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 as well as other sites in sub-Saharan Africa.

Meanwhile, a phase 2 open-label, randomised controlled study was conducted among 524 adults and children with acute uncomplicated malaria due to plasmodium falciparum infection. During the research the ganaplacide/lumefantrine-SDF combination met the primary objective in all patients.

In patients who received a once-daily dose of ganaplacide/lumefantrine-SDF during three days, response to treatment was similar to the rate observed in patients who received twice-daily artemether-lumefantrine control therapy during the same time period.

Dr Sujata Vaidyanathan, head of the global health development unit at Novartis, commented: “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.”

“The earlier we have new compounds and the faster the world adopts them, the better chance we stand of beating resistance,” he added.

“We are increasingly seeing parasites with decreased sensitivity to artemisinin, even in Africa,” concluded Dr Timothy Wells, chief scientific officer at MMV. “If the phase 3 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.”

According to the latest World Malaria Report – released in December 2021 – there were an estimated 241 million cases of malaria and 627,000 resulting deaths worldwide in 2020.