By Alex Baluku
New Orleans, 15 November 2024 – The WANECAM2 consortium has announced promising results from a Phase 2b clinical trial of a new malaria treatment that could offer an improved option for children as young as six months. The KALUMI study tested a novel combination of ganaplacide and lumefantrine, which proved to be as effective as the current standard, artemether-lumefantrine, for treating malaria in children. This new treatment, taken once daily over three days, could make it easier to follow the treatment regimen and improve adherence.
The study, which spanned multiple African countries including Burkina Faso, Mali, Gabon, the Democratic Republic of Congo (DRC), and Côte d’Ivoire enrolled 220 children, evenly divided between those treated with ganaplacide-lumefantrine and those with the standard treatment. Both groups achieved a 99% success rate by day 29, meeting the trial’s main objective of demonstrating non-inferiority to artemether-lumefantrine.
“Malaria remains a serious threat to children across Africa, with rising concerns of drug resistance,” said Prof. Abdoulaye Djimde, coordinator of the WANECAM2 consortium. “These results confirm the potential of ganaplacide-lumefantrine as a once-daily treatment, which may make it easier for caregivers and improve outcomes.”
With backing from Novartis, the Medicines for Malaria Venture (MMV), and funding from the European & Developing Countries Clinical Trials Partnership (EDCTP), the study signals the strength of international collaboration in combating malaria. Dr. Wiweka Kaszubska from MMV emphasized the importance of partnerships, particularly as drug resistance grows. “The success of this study underscores the impact of research collaborations, and we eagerly await the Phase 3 results,” she said.
The KALUMI trial’s positive outcome has led to a larger Phase 3 trial, known as KALUMA, now underway. Results are anticipated in 2025, and if successful, the ganaplacide-lumefantrine combination could offer a new tool in the fight against malaria, a disease that claimed over 608,000 lives in 2023, with children in Africa most affected.
While no serious drug-related adverse events were reported, there was a higher rate of vomiting among younger children treated with ganaplacide-lumefantrine. However, researchers noted that these side effects align with typical malaria treatment outcomes.
The findings were presented at the American Society of Tropical Medicine and Hygiene’s annual meeting this week in New Orleans, marking a critical step toward providing safer, more accessible malaria treatments for young children in malaria-prone regions.
