Imagine trying to find one key that opens four different locks; that is what this project does for worm infections. Instead of running four separate, slow tests, they use a flexible 'basket' method to test one drug against four diseases at once. This makes the process faster and cheaper while helping doctors in Africa get better diagnostic tools.
Current mass drug administration for tropical worms is inefficient and the clinical pipeline for new candidates is empty. Traditional clinical trials are too slow and expensive to address multiple rare or neglected diseases individually.
An adaptive clinical basket trial platform, a master protocol for 4 diseases, sensitive molecular assays, and an open-source virtual training tool for diagnosis.
If you are a generic drug manufacturer dealing with a lack of clinical candidate pipelines for tropical diseases — this project developed an adaptive clinical trial platform that provides proof of concept for oxfendazole. This allows for faster registration and a reduced number of trial participants.
If you are a digital health platform provider dealing with low diagnostic capacity in remote areas — this project developed a virtual training and assessment tool. This tool helps identify parasitic infections in Sub-Saharan Africa where laboratory services are limited.
If you are a molecular diagnostics lab dealing with imprecise mapping of disease prevalence — this project developed sensitive molecular assays. These tools enable a 'test and treat' approach for 4 different helminth diseases.
Based on available project data, the drug oxfendazole is described as cheap and freely-accessible, though specific pricing is not provided.
The project uses an adaptive clinical basket trial and master protocol, which is designed to reduce development time-frames and can be adapted for multiple diseases simultaneously.
Based on available project data, the virtual training tool is open-source, but specific licensing for the clinical platform is not mentioned.
Yes, the protocol was favorably reviewed by the European Medicines Agency (EMA), confirming the adaptation strategy for efficacy and safety.
The project period runs from 2023-04-01 to 2028-03-31, with mid-term interim analyses planned to adapt recruitment.
The consortium is composed of 10 partners across 7 countries, showing a strong international reach. It is heavily weighted toward research and academia (4 universities, 4 research institutes), with a low industry ratio of 10% (1 industry partner, 1 SME). This structure suggests the project is primarily focused on clinical validation and capacity building rather than immediate commercial product launch.
Contact Universitätsklinikum Bonn regarding the oxfendazole adaptive trial results.
Contact us to find partners for adaptive clinical trial implementation in emerging markets.
