Bayer to proceed with Phase 3 Nifurtimox trial

Bayer has formed a Phase 3 clinical trial that will assess the safety and effectiveness of Nifurtimox, a formulation designed to treat children of all ages that have been diagnosed with Chagas disease.
Bayer unveiled the new study at the American Society of Tropical Medicine and Hygiene's (ASTMH) 65th annual meeting.
Nifurtimox has not yet been approved by the U.S. Food and Drug Administration, and there are no other medicines approved for the treatment of Chagas disease in children.
"As the manufacturer of Nifurtimox, we have a long-term commitment to the fight against this disease," Bayer Pharmaceutical Division President Dieter Weinand said. "Children are the most vulnerable patient group. Every child who can be treated is a step toward getting the disease under control."
Chagas disease is caused by the Trypanosoma cruzi (T. cruzi) protozoan parasite, which makes this disease potentially life-threatening. More than 300,000 individuals in the U.S. are estimated to be infected with Chagas disease.
The pathogen causing the disease is transmitted from infected mother through pregnancy to her newborn, which is why children account for the majority of new infections.