STOP 2030 Explores New Formulation Against STH

The institute in collaboration with STOP2030 and European and Developing Countries Clinical Trials Partnership 3 (EDCTP3) Global Health convened a two-day workshop in Nairobi to evaluate the safety and effectiveness of a single dose Albendazole-Ivermectin co-formulation compared to the Albendazole preventive chemotherapy of Soil Transmitted Helminth (STH) Infections among school aged children.

The workshop which attracted delegates from the Ministry of Health, Ministry of Education, Neglected Tropical Diseases, Pharmacy and Poisons Board, Ghana Health Services, KEMRI among others and was officially presided over by Deputy Director ESACIPAC, Dr. Doris Njomo representing the Ag. DG Prof Elijah Songok.

In her welcoming remarks, Dr. Njomo highlighted on the project that is domiciled at ESACIPAC while noting the partnership offered by the institute through scientists and the Scientific Ethics Review Unit (SERU) to the consortium to ensure the success in eliminating STHs, “I am glad to invite you to our country Kenya and particularly to this workshop to discuss on the strides made and a way forward in having a fixed dose to benefit the deworming projects among school aged children. I want to assure you of the institute’s support through the necessary human resource and the available resources required towards seeing the success of this project. I urge you to intensely work to ensure the delivery of results that are much awaited towards the decline of STH as a package,” she said.

Soil-Transmitted Helminths (STH) are a group of parasitic worms that cause infections affecting approximately 1.5 billion people globally and impacts the nutritional wellbeing, particularly among children and women of reproductive age and are caused by the STHs- Ascaris lumbricoides, Trichuris trichiura, and the two hookworms, Necator americanus and Ancylostoma duodenale and causes devastating consequences to the community.

The WHO guidelines for STH have called for mass drug administration with benzimidazoles (albendazole or mebendazole) mainly to preschool-aged children, school-aged children and women of reproductive age complimented by improvements in water, sanitation and hygiene (WASH). However, the treatments face challenges in addressing Trichuris trichiura and Strongyloides stercoralis effectively and thus the Consortium has developed an innovative orodispersible tablet that co-formulates 400mg of albendazole with either 9mg or 18mg of ivermectin (FDC), with emphasis on improving cure rates against T. Trichiura and has seen strides in part of the clinical development plan.

The workshop featured well packaged presentations from leading researchers and health experts in the consortium who shared insights on formative studies conducted in Ghana and Kenya, Modelling STH, WHO guidance pathway and access planning for FDC, how to approach diagnostics in a program and in trials, acceptability study design and outcomes, milestones and deliverables for the years to come and the way forward.

An interesting open mic session brought a twist of liveness to the workshop where participants were given 5-minute presentations on own publications, progress of active projects and relevant papers from other authors and research.

Research scientist, Dr. Charles Mwandawiro highlighted on the current study (STOP 2030) that aims to evaluate and compare the safety and effectiveness of the fixed dose co-formulation (FDC) of Albendazole-ivermectin against Albendazole via mass drug administration; whose aim is to accelerate the implementation of an innovative treatment of worms scientifically known as Soil-Transmitted Helminth (STH) infections for pediatric population between five to 18 years-old and its results could provide invaluable information about the use of combination therapy with existing drugs against neglected tropical diseases which has been identified as a strategy that could offer a solution to the lack of investment by the pharmaceutical industry for the development of new therapeutic agents.

The delegates discussed on the challenges encountered in the study with the Project’s Principal Investigator Dr. Alejandro Krowiecki emphasizing on the need to bring everyone on board in terms of social mobilization, communication and reaching out to the community to gain guidance on the acceptability of the new interventions to eliminate misinformation and perceptions regarding the administration of the single dose.

The workshop marked a significant step in the fight against Soil Transmitted Helminth Infections and paved way for a more effective evidence-based interventions that would improve the health and wellbeing of children. It underscored the importance of continued partnership and research to optimize STH control by strengthening partnerships with different relevant stakeholders.