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Bayer announces late-stage study of pediatric formulation of Nifurtimox for Chagas disease

Published 11/15/2016, 07:30 AM
Bayer announces late-stage study of pediatric formulation of Nifurtimox for Chagas disease
BAYRY
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  • Bayer (OTCPK:BAYRY) announces a Phase 3 clinical, CHICO, assessing a pediatric formulation of Nifurtimox (an adult formulation is marketed by the company in South America as Lampit) for the treatment of children (including newborns) with Chagas disease, an infectious disease caused by single-cell parasites called trypanosoma. They are transmitted to humans via the feces/urine of kissing bugs, so named because they prefer to bite humans around the mouth or eyes.
  • CHICO is evaluating fast-disintegrating 30 mg and 120 mg tablets that can be divided for weight-adjusted doses in all age groups in ~390 children. The study is a two-arm design with 30-day and 60-day treatment cycles at 25 sites in Argentina, Colombia and Bolivia. Enrollment began in January 2016.
  • Although regarded as a tropical disease, it is believed that more than 300K Americans are infected with Chagas. Children are particularly at risk but they have the best chances of being completely cured.
  • The company announced the study at the 65th annual meeting of the American Society of Tropical Medicine & Hygiene in Atlanta, GA.

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