Steps for Advancing STOP2030 Treatment in Global Health
Alejandro Krolewiecki, MD discusses the path to regulatory approval, collaboration with global health organizations, and the role of partnerships in scaling up the new treatment for neglected tropical diseases.
The STOP2030 project in northwestern Argentina aims to develop more effective tools for controlling neglected tropical diseases (NTDs), particularly soil-transmitted helminths (STH). The study tests a combination of albendazole and ivermectin, which has shown improved efficacy against several STH species, including those resistant to standard treatments like albendazole and mebendazole. The ultimate goal is to create a broad-spectrum treatment for STH, which affects millions in tropical and subtropical regions.
In the next part of our interview with Alejandro Krolewiecki, MD, director of innovation at Mundo Sano and principal investigator of the STOP2030 project, discussed the path to bringing this treatment into widespread use begins with securing regulatory approval. “The first necessary thing that’s needed for this CO formulation is to gain approval by regulatory agencies to be transformed from an investigational product into an approved drug,” explained Krolewiecki. The treatment has already been submitted to the European Medicines Agency and the U.S. FDA, with plans to submit to additional regulatory bodies. Securing approval is a necessary step in ensuring that the product reaches the people who need it most.
Once approved, the next challenge will be integrating the treatment into global health strategies. Krolewiecki emphasized the importance of WHO’s role in ensuring that new treatments are considered for official recommendations. “Another step is to enter into pre-qualification at WHO because if we want this to become part of their recommendations, to reach the programs, that should be something much desirable,” he noted.
To advance this process, Krolewiecki and his team recently presented their findings at the INCORE NTD meeting in Kigali, Rwanda. The event focused on the African region and brought together healthcare workers and program managers. “Those are the venues where we want this to progress in order to gain impact,” said Krolewiecki, highlighting the importance of these international forums in making progress toward integrating the drug into existing programs.
While the new treatment is a tool in controlling helminth infections, Krolewiecki pointed out that long-term success will require structural development within affected communities. “Water, sanitation, hygiene, and economic development is the most powerful tool to control this type of disease,” he said. The treatment will complement these efforts by improving efficacy or adding efficacy in treating infected individuals, potentially helping to break the transmission cycle in key communities.
Krolewiecki noted that WHO’s goal for these diseases is not necessarily elimination, but rather control. “The goal from WHO is not elimination. Of course, everybody wants this not to become a problem in terms of morbidity,” he explained. “But the first step is to accomplish what WHO set for us as the goals for these diseases.”
One of the most important factors in the success of this project is the collaboration between various sectors, including academia, private industry, and government. “Projects like ours depend on private-public partnerships,” said Krolewiecki, “and the many partners we have, these come from academia, private industry, and government. It’s team work, and it has been since the beginning.”
