Novartis and Medicines for Malaria Venture announce positive efficacy and safety data for a novel treatment for babies <5 kg with malaria.

The trial was conducted in several African countries. The data, which will be presented this week at the Multilateral Initiative on Malaria (MIM Society) 8th Pan-African Malaria Conference in Kigali, have been submitted for regulatory review.

Malaria exerts a massive burden on public health across the world, particularly in Africa. Huge strides have been made in recent decades in the treatment of malaria. However, to date, little data has been generated in the smallest children – babies less than 5 kg.

“We are pleased with the positive outcomes from our CALINA study and to be one step closer to bringing an effective malaria treatment to all age groups, including vulnerable newborn babies," said Shreeram Aradhye, President, Development and Chief Medical Officer at Novartis. “We have been committed to the fight against malaria for more than two decades, and this successful trial represents another milestone towards ensuring that all people have access to an appropriate antimalarial therapy.”

The CALINA study is led by Novartis, with the scientific and financial support of Medicines for Malaria Venture (MMV), and as part of the PAMAfrica consortium, which is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP2). It is the first evidence-based trial conducted to evaluate a new antimalarial dose and regimen for all infants weighing under 5 kg with acute uncomplicated malaria. If approved, Novartis and MMV aim to make the treatment available as soon as possible to the youngest infants, who currently lack access to evidence-based treatment options.

The new formulation, known as Coartem <5 kg baby, uses a new ratio and dose of artemether-lumefantrine to account for metabolic differences in babies under 5kg. infants under 5 kg can be affected by placental malaria, leading to poor birth outcomes, or contract malaria from the bite of an infected mosquito. the prevalence of the disease in this age and weight group is poorly understood, and it is therefore often misdiagnosed.

Current antimalarials have not been developed specifically for infants weighing under 5 kg. There is no approved treatment available for them, and they are treated with tablets meant for children above 5 kg adjusted by weight. Yet, these tiny patients handle drugs differently due to the immaturity of their metabolizing organs, which can lead to overdose and toxicity. Coartem <5 kg baby provides optimized dosing specifically tailored to the needs of these vulnerable patients. if approved, the treatment will close a significant treatment gap.

“Infants below 5 kg make up a critical neglected group, and developing antimalarials specifically suited to their needs is essential to malaria control efforts,” said Wiweka Kaszubska, Executive Vice President, Head of Product Development, MMV. “The success of the CALINA trial brings us one step closer to ensuring that all patients have access to appropriate and effective treatments.”

This year's theme for World Malaria Day – Health Equity, Gender, and Human Rights – serves as a stark reminder of our collective responsibility to protect every child from malaria. It underscores the need to ensure that the youngest and most vulnerable among us also have access to the right treatment.

About the CALINA study; Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg body weight with acute uncomplicated plasmodium falciparum malaria (calina) is an open-label, single-arm, multicenter phase ii iii study in young infants>< 5 kg with uncomplicated Plasmodium falciparum malaria, which evaluated the PK, safety, tolerability and efficacy of a new dose regimen (5mg:60mg). The study consists of a core segment (treatment and follow-up for 43 days) and long-term follow-up at 12 months of age to assess neurodevelopmental status. The trial was conducted in Burkina Faso, DRC, Kenya, Mali, Nigeria, and Zambia. The primary PK endpoint of the study was met for patients less than 28 days of age. For neonates <= 28 days of age, although the sample size was too small for a conclusive statistical evaluation, the required value of the pk endpoint was also within the calculated interval. the key secondary endpoint of lumefantrine c168 concentration was also met for cohort 1 and within range for cohort 2. this indicates that the new dose regimen formulation delivers exposures to artemether and lumefantrine proven to be safe and effective in paediatric patients of higher body weight.