The pharmaceutical giant, Bayer, began enrolling participants in a Phase III clinical trial in January 2016 with hopes to find appropriate dosing of Nifurtimoxin for children and newborns.
Individuals living in the poorest conditions throughout the Americas are often faced with squalor and diseases that impact them in unimaginable ways. On the heels of a recent announcement from major pharmaceutical company, Bayer, however, hope for one such disease may be on the horizon.
In a press announcement yesterday morning at the 65th Annual American Society of Tropical Medicine & Hygiene Meeting (ASTMH) in Atlanta, Georgia, Bayer revealed that it will be initiating a Phase III clinical study to evaluate, “the efficacy and safety of a newly developed formulation of the investigational medication Nifurtimox in children of all age groups who have been diagnosed with Chagas disease.” What makes this announcement particularly intriguing is that Nifurtimox is not currently approved by the Food and Drug Administration (FDA) and indeed, “there are no FDA-approved treatments for children with Chagas disease,” according to the press release.
Chagas disease, also known as American trypanosomiasis, is exclusively found in the Americas, and is endemic in Mexico, Central America, and South America. The potentially deadly disease is caused by a parasite, Trypanosoma cruzi, and is transmitted to humans from insect vectors. According to the Centers for Disease Control and Prevention (CDC), “infection is most commonly acquired through contact with the feces of an infected triatomine bug (or "kissing bug"), a blood-sucking insect that feeds on humans and animals.” In the United States, an estimated 300,000 individuals are infected with the disease, according to the CDC. Most of these cases are thought to be travel-related due to an increase in travel and migration and although the triatomine bug is found in the United States, only rare cases of infection have been documented.
Due to the fact that the infection is often congenital, infants and children represent the majority of the infected population. As such, “treatment of women of child-bearing age and children is an effective tool in combating the spread of disease.”
The Phase III clinical trial is entitled the CHICO study, or, “CHagas disease In Children treated with NifurtimOx." It is a “prospective historically controlled study to evaluate the efficacy, safety and pharmacokinetics of Nifurtimox in children (up to the age of 17) with Chagas disease.” Since January 2016, a total of 390 pediatric patients have been enrolled in the study, which will take place in 25 locations in three countries: Argentina, Colombia, and Bolivia.
The two-arm study features 30- and 60-day treatment cycles which will be compared with an historical untreated control. The researchers will attempt to develop “an appropriate, weight-adjusted dose of Nifurtimox for newborns and children using fast-disintegrating 30mg and 120mg tablets that can be divided for weight-adjusted dosing in all age groups.”
Once the study is successfully completed, “Bayer plans to register Nifurtimox both in disease-endemic and in non-endemic countries with disease burden.”