Novartis and Medicines for Malaria Venture Announce Favorable Outcomes from Phase II/III Study of Coartem in Treating Malaria in Infants

An illustrated scene of scientists from Novartis and Medicines for Malaria Venture celebrating in a laboratory, surrounded by images of the Coartem medication and a smiling infant symbolizing recovery from malaria.

Novartis and Medicines for Malaria Venture Announce Promising Phase II/III Trial Results for Coartem in Infants

In a significant advancement against pediatric malaria, Novartis, in partnership with the non-profit organization Medicines for Malaria Venture (MMV), has reported positive outcomes from a recent Phase II/III clinical trial evaluating the efficacy and safety of Coartem® Dispersible in treating infants diagnosed with malaria. This groundbreaking study marks a crucial step forward in the global fight against this deadly disease, offering hope for one of the most vulnerable populations affected by malaria: infants.

About the Clinical Trial

The comprehensive Phase II/III trial was conducted across several sub-Saharan African countries, where malaria incidence is among the highest globally. The study aimed to assess the effectiveness and safety profile of Coartem® Dispersible, an antimalarial medication specifically formulated for children, in infants weighing 5 to less than 10 kilograms. Over the course of the trial, researchers observed not only a high efficacy rate but also a favorable safety and tolerability profile of Coartem® Dispersible in this young patient population.

Key Findings and Implications

The trial’s findings demonstrated that Coartem® Dispersible, when administered to infants with uncomplicated Plasmodium falciparum malaria, effectively cleared the infection and prevented recurrence over a 28-day follow-up period. The treatment was well-tolerated among participants, with most adverse events being mild to moderate in nature and consistent with symptoms of malaria. These results underscore Coartem® Dispersible’s potential as a safe and effective treatment option for infants suffering from malaria, addressing a critical gap in pediatric malaria care.

Global Impact of Malaria on Infants

Malaria remains one of the leading causes of morbidity and mortality in children under the age of five, particularly in Sub-Saharan Africa. According to the World Health Organization (WHO), children in this age group accounted for approximately 67% of global malaria deaths in 2020. Infants are particularly vulnerable to severe outcomes from malaria infections, making the development of effective and safe treatments for this age group a public health priority.

Novartis and MMV’s Commitment to Fighting Malaria

Novartis and MMV have a long-standing partnership in the fight against malaria, having collaborated on the development and dissemination of antimalarial treatments for over a decade. The positive results from the Coartem® Dispersible trial reinforce both organizations’ commitment to advancing global health by developing innovative treatments that can save the lives of those most at risk of malaria. Looking ahead, Novartis and MMV plan to pursue regulatory submission for Coartem® Dispersible for infants based on these promising trial results, aiming to make this vital treatment available to those in need as swiftly as possible.

As the fight against malaria continues, innovative partnerships like that of Novartis and MMV, alongside breakthroughs in pediatric treatment options, are essential in reducing the disease burden and ultimately saving lives. The success of the Coartem® Dispersible trial for infants is a beacon of hope, representing a significant leap forward in the pursuit of a malaria-free future for children worldwide.