Novartis plans to take malaria treatment through to P3 trials

The two partners will progress a combination of ganaplacide and lumefantrine, in a solid dispersion formulation, into Phase III development for the treatment of patients with acute uncomplicated malaria due to Plasmodium falciparum.​

Novartis and Medicines for Malaria Venture (MMV) are pursuing further development of the treatment after Phase II trials showed that it is has the potential to both clear malaria infection and to block the transmission of the malaria parasite.​

In addition, the potential treatment also has a simpler treatment schedule, requiring dosing only once per day, as opposed to twice-daily when patients receive ​artemether-lumefantrine.

The partners stated that they plan to take the combination therapy into one large Phase III pivotal trial in 2023. It is planned for the treatment to be compared against artemether-lumefantrine, which the organizations referred to as the ‘gold standard’ of treatment.

The Phase III study will be conducted alongside the WANECAM 2 consortium, with clinical sites being located across Burkina Faso, Mali, Gabon and Niger, as well as other sites in sub-Saharan Africa.

Beyond simply providing an alternative treatment option, the organizations stated that there is a need to combat growing resistance to current important therapies against malaria.

“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,”​ said Sujata Vaidyanathan, head of Novartis’ global health development unit.

Artemisinins are an anti-malarial treatment that are extracted from the sweet wormwood plant. It has been used for malaria treatment in China for over 1,000 years, but was established as a viable therapy after artemisinin was first extracted by Chinese researchers in 1972.

The current gold standard treatment of artemether-lumefantrine is artemisinin-based.

A global effort​

Ganaplacide has been developed through the Wellcome Trust, MMV and Singapore Economic Development Board, alongside Novartis and the Swiss Tropical and Public Health Institute.

The research that led to the potential new treatment option is being supported by the European Union, through the European and Developing Countries Clinical Trials Partnership, which provided funding for both Phase II and the upcoming Phase III trial.

In August 2022, the US Food and Drug Administration granted the potential new treatment fast track designation and orphan drug designation for the treatment of acute, uncomplicated malaria.