An article on LinkedIn from Trevor Mundel, President of Global Health at Gates Foundation announced phase III trial for ganaplacide-lumefantrine (GanLum), a new non-artemisinin malaria treatment being developed by Swiss Pharma Giant, Novartis. The posting linked to web post from NPR. ‘New malaria drug could be a life-saver as the standard drug shows signs of weakness’ by Jonathon Lambert has preliminary results of a study which enrolled over 16,000 adults and children over 2 years old with malaria across a dozen countries in Africa. Half took GanLum over the course of three days and half got the current artemisinin-based standard of care.
The team found both drugs were about equally effective, with GanLum coming out slightly on top. Both drugs had similar levels of side effects, including nausea and diarrhoea. But the GanLum group did experience more vomiting.
Hardly, a game changer. The reason given for its development is that there are fears that artemisinin based drugs might lose their effectiveness. Lumefantrine features in the treatment as it does in one of the most commonly used treatments today, the artemisinin based artemether-lumefantrine.
I sought more information and found the Phase II trial on clinicaltrials website, ID NCT04546633. ‘Ganaplacide (KAF156) plus lumefantrine solid dispersion formulation combination for uncomplicated Plasmodium falciparum malaria: an open-label, multicentre, parallel-group, randomised, controlled, phase 2 trial’ by Ogotu et al was published in the Lancet in 2023. The study for which 1220 patients were screened funded by Novartis and Medicines for Malaria Venture found little difference between it and control, also artemether-lumefantrine.
The article does state that GanLum won’t replace artemisinin remedies any time soon.
I suspect the real motivation for its development is to have a product upon which the patent royalties have not expired. Wikipedia informs that Ganaplacide is protected by the granted United States Patent 9,469,645. This is now owned by Novartis International Pharmaceutical Ltd., Bermuda.
Why else would Novartis be motivated to fund studies?