Ganaplacid/lumefantrine in new study as the world faces emerging resistance to malaria treatments
Novartis and Medicines for Malaria Venture MMV announced that they will advance the ganaplacid/lumefantrine solid dispersion formulation (SDF) into Phase 3 development.
The treatment targets patients with acute uncomplicated malaria due to plasmodium falciparum and is in response to increased concerns about resistance to existing therapies.
Ganaplacid is a new agent with a new mechanism, which is combined with a once-daily formulation of lumefantrine. This combination has the potential to cure malaria infections – including artemisinin-resistant strains – while also blocking transmission of the parasite. The drug is currently being developed with scientific and financial support from MMV and their partners.
A large pivotal Phase 3 study, starting in 2023, will compare the efficacy of ganaplacid/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 clinical partner sites in Burkina Faso, Mali, Gabon and Niger, as well as other sites in sub-Saharan Africa.
Meanwhile, a phase 2 open-label, randomized controlled trial was conducted in 524 adults and children with acute uncomplicated malaria due to plasmodium falciparum infection. During the study, the ganaplacid/lumefantrine-SDF combination met its primary goal in all patients.
In patients who received ganaplacid/lumefantrine-SDF once daily for three days, treatment response was similar to that observed in patients who received artemether-lumefantrine control therapy twice daily for the same period.
Dr. Sujata Vaidyanathan, Head of the Global Health Development Unit at Novartis, commented: “The emergence of artemisinin resistance requires urgent action to develop new antimalarials. We need non-artemisinin-based drugs with novel mechanisms of action against drug-resistant parasites, and simple, easy-to-follow dosing schedules to increase adherence.”
“The sooner we have new connections and the faster the world takes them over, the more likely we are to defeat the resistance,” he added.
“We are increasingly seeing parasites with reduced sensitivity to artemisinin, even in Africa,” concludes Dr. Timothy Wells, MMV’s head of scientific research. “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 latter World Malaria Report – released in December 2021 – there were an estimated 241 million cases of malaria worldwide in 2020 and 627,000 deaths as a result.