A unique approach to helminthiasis treatment

Unleashing the power of combination

Five species, two drugs, one pill

An affordable and efficient tool to control infection

Our approach at STOP2030 is to combine two existing drugs into a single tablet that allows a more efficient and affordable treatment of helminthic infections. These two compounds are albendazole and ivermectin, both anthelmintics already licensed and widely used around the world. Their mechanisms of action are different, resulting in a broader efficacy and minimising the risk of resistance. This fixed-dose coformulation has been proven safe and effective in our previous clinical trials and is in the last stages of development before regulatory approval.

Ivermectin

Albendazole

Starting in July 2023

From Africa and Europe

In funding by Global Health EDCTP

In funding by the Swiss Government

WP1

Led by Liconsa

Lead the project’s progress and partner efforts towards achieving its objectives, managing all administrative, financial and legal matters. Liconsa will produce the fixed-dose combination of ivermectin and albendazole and carry out its registration at the relevant drug agencies.

WP2

Led by ISGlobal

Design and execute a safety and effectiveness pragmatic trial for the coformulation, as well as a nested study to evaluate its impact on strongyloidiasis and scabies.

Evaluate the effectiveness of deworming programmes and potential resistance using genomic epidemiology data.

WP3

Led by KEMRI

Perform data analysis and modelling to inform evidence-based decision making on the implementation scenarios for the coformulation, as well as providing the data management for scientifically robust statistical analysis on the coformulation’s safety, effectiveness, cost-effectiveness, acceptability, and feasibility.

WP4

Led by GHS

Conduct a multi-country formative study, and use its results to develop and conduct a multi-country acceptability, feasibility, and adherence study.

WP5

Led by Bridges to Development and Mundo Sano

Define a pathway to regulatory guidance for the use of the coformulation in STH and other NTDs, as well as disseminate the project’s results and applications.

The objectives that drive us forward

Our project’s goals

All STOP projects were created with the same purpose: to advance and accelerate an innovative pharmacological tool to support the elimination goals against STH species, especially those that respond poorly to current treatment regimens. After our trajectory in the previous years, the development of our fixed-dose coformulation (FDC) has advanced to the point of reaching phase IV clinical testing in this last STOP2030 project.

Our goal is to support the achievement of the WHO 2030 Neglected Tropical Diseases Roadmap for Soil-Transmitted Helminths (STH) and beyond.

Next steps of STOP2030

Submission of the FDC to regulatory agencies

To the European Medicines Agency (EMA) and the national agencies in Ghana and Kenya

Testing of FDC’s safety and effectiveness

Evaluate the safety and effectiveness of the FDC for the control of STH and the integration with other neglected tropical diseases with the REALISE study.

Evaluate acceptability, feasibility and adherence

Gather acceptability, feasibility and adherence data of the FDC to complete the evidence package and support WHO guidance

Creation of an access plan for implementation

Develop a model for sustainable supply and costing, as well as impact models in different use cases and scenarios.

Monitoring of drug resistance

Pilot antihelmintic resistance surveillance based on genetic epidemiology.

Already accomplished milestones

Qualification of the FDC at EU_M4All (previously known as article 58)

Proved safety of ivermectin of up to 600μg/kg (Matamoros et al, 2021 and Navarro et al, 2020)

Kick-off of the STOP2030 project

Visit to Ghana’s study site

Entered in EMA for evaluation and its scientific opinion

Approval of the Formative Study of Acceptability, Feasibility and Adherence by the Ethics Committee of the Ghana Health Service

Publication of the REALISE trial protocol in clinicaltrials.gov and PACTR (id: PACTR202402529220760)

Submission of the FDC to the Ghana FDA for registration

The GHS Ethical Review Committee approval of the REALISE study

The Lancet Infectious Diseases publishes the results of our phase 2-3 trial that show the safety and efficacy of the FDC

The European Medicines Agency (EMA) publishes a positive scientific opinion of the FDC

Going beyond science

Research towards implementation

The development of a new drug is not enough to stop soil-transmitted helminths (STH). Other considerations like ensuring affordable pricing, sustainable financing, and planning the best implementation strategy with key stakeholders are essential for long-term success. In order to make the new treatment a real option, including for the poorest and most neglected communities, we also prepare the regulatory and supply pathways for implementation.

A coformulation of ivermectin and albendazole was already recognised as the option with the lowest level of investment risk of all candidates according to experts in the field (Gates Foundation 2016). Now by engaging policy and decision-makers internationally and in governments, we aim to support the future use of this new treatment and make real strides to control the unbearable burden of intestinal worms.

Filling the gap in the administration

A new approach to reach international objectives

Previous strategies have been insufficient to reach the World Health Organisation’s objectives in STH control. In their latest roadmap for 2030, they aim to achieve and maintain elimination of STH-associated morbidity in children (<2% prevalence). Given the concerns in current control strategies using benzimidazoles (albendazole or mebendazole), our new combined approach can work as a solution soon ready for scale up in countries.

Getting the most out of our work

Potential implementations beyond soil-transmitted helminths

Some of the innovations developed during our STOP projects could be of use for other neglected tropical diseases (NTDs). One example is the fixed-dose ivermectin. This formulation reduces the risk of dosing errors based on measurements by hand and removes the need for scaling materials that are often not available. These are benefits applicable to other NTDs currently treated with ivermectin, such as elephantiasis (lymphatic filariasis).