Novartis and Medicines for Malaria Venture (MMV) have unveiled encouraging results from their phase II/III CALINA trial, indicating that a newly formulated version of Coartem® (artemether-lumefantrine) tailored for infants weighing under 5kg with malaria demonstrates the necessary pharmacokinetic profile, along with commendable efficacy and safety. Conducted across multiple African nations, the findings will be presented at the Multilateral Initiative on Malaria (MIM Society) 8th Pan-African Malaria Conference in Kigali and have been forwarded for regulatory assessment.
Malaria remains a formidable public health challenge globally, especially in Africa,1 where significant progress has been made in its treatment over recent decades. Yet, scant data exists for the youngest demographic – infants under 5kg.
Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis, expressed satisfaction with the outcomes, highlighting the significance of advancing malaria treatment to encompass all age groups, including the most vulnerable newborns. This milestone marks another stride in Novartis’ longstanding commitment to combat malaria.
Led by Novartis and backed by MMV and the PAMAfrica consortium, with funding from the European & Developing Countries Clinical Trials Partnership (EDCTP),2 the CALINA trial represents the first systematic examination of a novel antimalarial dosage and regimen for infants under 5kg with acute uncomplicated malaria. Pending approval, Novartis and MMV aspire to swiftly make this treatment accessible to the youngest patients, currently lacking evidence-based therapeutic options.
Dubbed Coartem <5 kg Baby, the new formulation employs an adjusted ratio and dose of artemether-lumefantrine to accommodate metabolic disparities in infants under 5kg.
Infants under 5kg face risks of placental malaria, leading to adverse birth outcomes, or contracting malaria from mosquito bites. Their susceptibility to the disease is poorly understood, often resulting in misdiagnosis.
Presently, antimalarials aren’t tailored for infants under 5kg, who are administered adjusted doses meant for older children. However, these tiny patients metabolize drugs differently due to immature organs, heightening the risk of overdose and toxicity. Coartem <5 kg Baby offers optimized dosing tailored to their unique requirements, aiming to address a critical treatment gap if approved.
Wiweka Kaszubska, MMV’s Executive Vice President and Head of Product Development, stressed the significance of tailored antimalarials for this overlooked demographic, emphasizing the CALINA trial’s advancement towards ensuring all patients access appropriate treatments.
Pauline Beattie from EDCTP underscored the importance of collaborative efforts between Europe and Africa in closing malaria treatment gaps for vulnerable populations.
This year’s World Malaria Day theme, “Health Equity, Gender, and Human Rights,” serves as a poignant reminder of our collective obligation to shield every child from malaria, emphasizing the imperative of providing the right treatment to the youngest and most vulnerable individuals.
