ATLANTA, Nov. 15, 2016 /PRNewswire/ -- Bayer announced today a Phase III clinical study evaluating 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. The announcement was made at the 65 th annual meeting of the American Society of Tropical Medicine & Hygiene (ASTMH) in Atlanta. Nifurtimox is not approved by the U.S. Food and Drug Administration (FDA) and there are no FDA-approved treatments for children with Chagas disease.
Chagas disease is a potentially life-threatening illness caused by the protozoan parasite Trypanosoma cruzi (T. cruzi). It's estimated more than 300,000 people in the United States are infected with Chagas disease i. The pathogen is often transmitted by an infected mother to her newborn during pregnancy or childbirth. Children, therefore account for the majority of new infections. In addition to systematic screening and diagnosis, treatment of infected women of child-bearing age and children is an effective tool in combating the spread of disease. "As the manufacturer of Nifurtimox, we have a long-term commitment to the fight against this disease," said Dieter Weinand, Member of the Board of Management of Bayer AG and President of Bayer's Pharmaceuticals Division. "Children are the most vulnerable patient group. Every child who can be treated is a step toward getting the disease under control." Nifurtimox is on the World Health Organization's (WHO) list of "Essential Medicines" for both adults and children. The WHO is distributing Nifurtimox in its efforts to control Chagas disease by 2020. Since 2004, as part of Bayer's commitment to neglected tropical diseases, the company has given the WHO a permanent supply guarantee for Nifurtimox and provided financial assistance to support logistics and drug distribution.