Phase III trial of Lampit meets primary endpoint in study of Chagas disease

Bayer presented results from the CHICO part (CHagas disease In Children treated with NifurtimOx) of the phase III clinical study of Lampit (nifurtimox) in pediatric patients with Chagas disease. The study met its primary endpoint, which was the serological response at one year after end of treatment, by demonstrating superiority of the 60-day nifurtimox treatment compared with historical placebo control. Safety and efficacy were evaluated throughout the clinical trial. CHICO was the first part of a prospective, randomized (to dosing regimen), double-blind, historically placebo controlled phase III trial to evaluate the efficacy, safety, and pharmacokinetics of nifurtimox in 330 pediatric patients with acute or chronic Chagas disease. The study was conducted at 25 investigational sites in Argentina, Bolivia and Colombia between 2016 and 2018. Data were presented at the "XV Taller sobre la enfermedad de Chagas" conference.

Comment: The treatment of Chagas disease is based on only two nitroheterocyclic compounds, nifurtimox and benznidazole. Nifurtimox is not approved by the FDA, but is currently available in the U.S. as a 120 mg tablet exclusively through the CDC under an investigational protocol. For the CHICO trial, Bayer developed a new formulation of both the 30 mg and 120 mg tablets, which can be dissolved in water to form a slurry when administered to pediatric patients. The new formulations were developed to allow for dosing accuracy and administration to those who have difficulty swallowing tablets, especially young children.