Our latest clinical trial, the REALISE study, has officially started its clinical phase. The First Patient First Visit (FPFV) took place on late September 2025, as sample collection and dosing started in Kenya’s Kwale region. This is an important moment for the STOP2030 consortium in our mission to deliver a better pharmacological tool for the control of Neglected Tropical Diseases (NTDs) and advancing the fixed-dose coformulation (FDC) of ivermectin and albendazole towards mass adoption. The study is one of the project’s cornerstone actions and will be carried out in Ghana and Kenya during the following months. Several members of the STOP2030 consortium are on the ground to support the teams carrying out the fieldwork.

“Reaching First Patient First Visit is a proud moment for the STOP2030 consortium”, said Dr. Alejandro Krolewiecki, the project’s Principal Investigator, from Liconsa. “The REALISE study is a sizeable clinical trial that aims to expand the evidence on the safety of the FDC, and the team has been working tirelessly to reach this milestone.”

The Ghanaian arm of the trial is expected to start soon. “Pre-screening activities have faced challenges due to heavy rainfall in the trial area and the fact that many children accompany their parents to the farms,” explained Dr. Joseph Opare, from the Ghana Health Service (GHS) and a member of the STOP2030 consortium. “Despite these obstacles, and with an ambitious target of screening 10,000 children aged 5 to 17 years, the Ghana team remains committed to completing pre-screening within the next few weeks. This will be followed by school-based screening, drug administration and subsequent follow-up activities.”

As a primary endpoint, the REALISE study will evaluate the safety of our fixed-dose combination treatment compared to the current standard, single-dose albendazole, in real-world conditions. Secondary goals include assessing effectiveness against T. trichiura, hookworms, A. lumbricoides, and S. stercoralis, as well as monitoring the emergence of resistance.

With a planned enrolment of approximately 20,000 school-aged children across Ghana and Kenya, the study is designed to provide critical insights into how these treatments perform in settings where soil-transmitted helminth (STH) infections are common.

The launch of the study follows encouraging developments for the FDC: earlier this year, the European Medicines Agency (EMA) issued a positive scientific opinion on the FDC, supporting its use for STH and lymphatic filariasis. “The development of Ivermectin/Albendazole holds a high public health value as it will bring concrete advantages to the effectiveness of mass administration programmes in countries where these diseases are endemic. It will help reduce the risk of incorrect dosage, improve adherence, and reduce manufacturing and transport costs. Ultimately, this will allow more people to be treated,” said the European regulator.