Bayer Clinical Study of Tropical Disease Treatment Met Endpoint

| By | Bayer, Clinical Study, Phase III

Largest clinical treatment study to date in pediatric patients with Chagas disease.

Bayer today presented the results of the CHICO (CHagas disease In Children treated with NifurtimOx) phase III clinical study of nifurtimox in pediatric patients with Chagas disease at the “XV. Taller sobre la enfermedad de Chagas” conference in Barcelona.

CHICO was a prospective, randomized, double-blind, historically controlled phase III trial to evaluate the efficacy, safety, and pharmacokinetics of nifurtimox in 330 pediatric patients with acute or chronic Chagas disease conducted at 25 investigational sites in Argentina, Bolivia, and Colombia between 2016 and 2018.

The study met its primary endpoint by demonstrating the superiority of the 60-day nifurtimox treatment compared with historical placebo control in serological response at one year after end of treatment. In the overall study population, the serological response to a shorter nifurtimox treatment duration of 30 days was lower when compared to the 60-day treatment. Treatment with nifurtimox at body weight-adjusted dosing showed a good safety profile.

An adequate dispersable formulation of nifurtimox is a big step forward toward achieving the goal of treating all infected children. Early treatment after infection is very important to prevent manifestation of the disease in adulthood,

said Dr Jaime Altcheh,
Head of the Department of Parasitology
and Chagas disease at the Ricardo Gutierrez
Children’s Hospital in Buenos Aires, Argentina,
and Coordinating Investigator of the phase III CHICO trial.

The targets for controlling Chagas disease are eliminating transmission, controlling the vector, treating girls and women at childbearing age (to avoid transplacental transmission), and testing blood prior to transfusion. In addition, the aim is to make healthcare access available for the infected population at all stages of the disease.

The treatment of Chagas disease is based on only two nitroheterocyclic compounds, nifurtimox and benznidazole. To date, nifurtimox has only been available as a 120 mg tablet, which is difficult to administer, especially to younger children. Bayer has now developed a 30 mg tablet. Both tablets are now fast dispersible formulations, which can be easily divided. They can also be rapidly dissolved in water to form a slurry, which can be given to those with difficulties in swallowing tablets. The new formulations were successfully used in CHICO and will improve dosing accuracy, safety, and adherence to treatment in children of all age groups.

Children are the most vulnerable patient group suffering from Chagas disease. With the successful completion of the CHICO study, an important milestone of our long-standing commitment to improve the treatment of Chagas has been achieved,

said Dr Joerg Moeller,
Member of the Executive Committee
of Bayer AG´s Pharmaceutical Division
and Head of Research and Development.

The majority of infections are asymptomatic. Symptomatic cases only show minor, flu-like symptoms which appear directly after infection. About two months later, Chagas disease enters a chronic stage that progresses for years, leading to severe organ damage and finally to sudden cardiac death. Education, early diagnosis, and treatment are essential in the fight against Chagas disease.

Today fewer than 1% of people infected with Chagas disease are treated due to low disease awareness and limited access to treatment. Bayer is committed to improving access to nifurtimox by new applications for registrations and making the new formulations available in countries with a high disease burden.

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