PATH announced today that it has received a grant from the Japanese Global Health Innovative Technology Fund (GHIT) to develop a new oral treatment option for soil-borne helminth infections (STH). PATH’s Vaccine and Pharmaceutical Formulation team, part of the global Medical Devices and Health Technologies program, will lead the international collaboration, which includes the University of Massachusetts Medical School (UMMS) in the United States and Kao Corporation in Japan.
Soil-borne helminths are parasitic worms, such as hookworms, roundworms, and whipworms. STH infections can deprive the body of blood and nutrients, disproportionately affecting populations living in poverty mainly due to the morbidity associated with malnutrition and anemia.
Severe anemia in pregnancy contributes significantly to maternal mortality. STH infections can be prevented and treated with benzimidazole. However, according to the World Health Organization, around 1.5 billion people are infected with this neglected tropical disease around the world.
Current mass drug prevention (MDA) campaigns in endemic locations are limited by three primary biological factors: reduced efficacy against Trichuris (whipworms), possible emergence of drug resistance, and limited use of benzimidazole for pregnant women, as well as logistics and financial constraints.
The PATH-led multisectoral team will focus on optimizing the antiparasitic protein Cry5B (a naturally occurring protein from the soil bacterium Bacillus thuringiensis), with the aim of producing an affordable, broad spectrum Cry5B product suitable for use by adults, children and pregnant women alternatively or in combination with existing benzimidazoles used in MDA antihelminthic campaigns.
Studies have shown that Cry5B has promising potential for the treatment of hookworms and roundworms and have shown strong activity against Trichuris in vitro.
It is estimated that 20 to 60 Cry variants will be produced by Kao Corporation in their Bacillus-based expression system and then tested in vitro and in vivo at UMMS. Based on these study results, an advanced Cry sequence will be selected for large-scale production for further development, with the aim of helping to expand the reach of anti-helminthic MDA campaigns and reduce the global burden of STH infections.
Cry5B therapeutic protein should be administered via potent and unique formulations for pediatric administration and which protect the oral drug from degradation during transit to the gastrointestinal tract, where parasitic worms reside.
This work will build upon the previous PATH GHIT Fund-supported drug development project, which focused on developing an appropriate Cry5B protein as a novel therapeutic option for STH management.