Novartis and Medicines for Malaria Venture (MMV) have announced plans to advance a ganaplacide/lumefantrine- solid dispersion formulation (SDF) into a Phase III clinical trial to treat individuals with acute uncomplicated malaria caused by Plasmodium falciparum.
The trial will analyse the efficacy of ganaplacide/lumefantrine-SDF versus the existing ‘gold standard’ of artemether-lumefantrine.
To be carried out in partnership with the WANECAM 2 consortium, the trial is anticipated to commence next year.
It will have partner trial sites in Mali, Burkina Faso, Gabon, Niger, and other sub-Saharan African sites.
A new agent, ganaplacide has a novel mechanism of action. It is combined with the latest lumefantrine formulation for dosing once a day.
This combination could possibly clear the malaria infection, including artemisinin-resistant strains, and hinder the malaria parasite’s transmission.
MMV chief scientific officer Dr Timothy Wells said: “We are increasingly seeing parasites with decreased sensitivity to artemisinin, even in Africa.
“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.”
According to data from an open-label, controlled, randomised Phase II trial in 524 adults and children with acute uncomplicated malaria due to Plasmodium falciparum infection, the combination treatment met the primary objective.
Response to treatment in subjects who were given once-a-day doses of ganaplacide/lumefantrine-SDF for three days was in line with those reported in patients who received twice-a-day doses of artemether-lumefantrine control therapy.
The combination therapy received Fast Track Designation and Orphan Drug Designation from the US Food and Drug Administration to treat acute, uncomplicated malaria in August this year.
In September this year, Novartis reported findings from two Phase III trials where its Cosentyx (secukinumab) provided quick and durable relief from common clinical signs and symptoms of moderate-to-severe hidradenitis suppurativa.