A promising new malaria treatment, Ganlum, has shown comparable effectiveness to the widely used Coartem in late-stage clinical trials, offering a potential breakthrough in the fight against a disease that killed an estimated 597,000 people globally in 2023[[2]]. Developed by Novartis and the Medicines for Malaria Venture, Ganlum targets drug-resistant parasites – a growing concern notably in Africa, where resistance to artemisinin-based therapies is on the rise[[1]]. The new drug is anticipated to undergo FDA review wiht potential availability in affected countries within the next year to eighteen months.
A new malaria drug has demonstrated effectiveness comparable to the current standard treatment, Coartem (artemether-lumefantrine), and offers a potential weapon against drug-resistant parasites. Malaria remains a significant global health challenge, particularly in Africa, making the development of new treatments crucial.
The treatment, called Ganlum, combines lumefantrine with ganaplacide, a novel active ingredient belonging to the imidazolopiperazine class. Researchers say ganaplacide works by disrupting the parasite’s internal protein transport systems, which are essential for its survival inside red blood cells.
Novartis, in partnership with the non-profit organization Medicines for Malaria Venture (MMV), developed Ganlum. Phase III trial results, presented by Novartis on November 12, showed the treatment achieved greater than 97% efficacy, compared to 94% for Coartem.
The trial involved 1,688 adults and children across 34 sites in 12 African countries, all diagnosed with acute uncomplicated Plasmodium falciparum malaria. Ganlum was administered as granules in sachets, once daily for three days.
According to Novartis, further analysis indicated the treatment was highly effective against mutant strains of malaria associated with partial drug resistance. It also rapidly cleared mature gametocytes, the sexual stage of the parasite’s life cycle responsible for transmission.
A Hope for Africa
These findings offer renewed hope in the fight against malaria in Africa, where parasite resistance to artemisinin – a component of Coartem – is growing. This resistance first emerged in Cambodia roughly two decades ago and spread through the Mekong region.
The phenomenon is now a concern in several African countries, with partial resistance confirmed in Eritrea, Rwanda, Uganda, and Tanzania. Experts fear that continued spread of resistance could diminish the effectiveness of artemisinin-based combinations, which are currently the mainstay of malaria treatment.
“Antimalarial resistance is an imminent threat: without action today, lives will be lost,” warned Dr. Martin Fitchet, President and CEO of MMV. He considers the Phase III results of Ganlum “a key step towards a new tool to control this phenomenon.”
Dr. Abdoulaye Djimdé, a professor at the University of Science, Techniques and Technologies of Bamako, Mali, echoed this sentiment, stating, “Ganlum could represent the biggest breakthrough in malaria treatment in decades, thanks to its high efficacy against multiple forms of the parasite and its ability to eliminate mutant strains showing signs of resistance to current drugs.”
La résistance aux antipaludéens est une menace imminente : sans action aujourd’hui, des vies seront perdues
Dr Martin Fitchet, président-directeur général de MMV
Novartis announced it will now submit an application for marketing authorization to the Food and Drug Administration (FDA). The company anticipates Ganlum could be available in affected countries within one to eighteen months, on a non-profit basis.
If approved, Ganlum would represent the first major innovation in malaria treatment since 1999. It has the potential to eliminate drug-resistant parasites and block parasite transmission by targeting the stage where it can be re-transmitted from an infected patient to a mosquito vector. This dual action could significantly reduce the spread of the disease.
