Members of the STOP consortium met in Kwale, Kenya, to discuss progress made and actions ahead
On January 16 and 17, STOP team members came together in Kwale, Kenya for the consortium’s fifth annual meeting. During those two days, team members from Spain, UK, the Netherlands, Kenya, Mozambique and Ethiopia presented ongoing results and discussed actions ahead.
“This was an important year for the project: we completed the Phase II and kick-started the Phase lll of the ALIVE clinical trial.” says Jose Muñoz, ISGlobal researcher and project leader.
During the two-day meeting, team members presented the results of the trial’s Phase ll, which focused on assessing the safety of the trial drug. This phase of the trial was conducted by the Kenyan Medical Research Institute (KEMRI) in Kenya in April 2022 and included 127 children. After Having observed no serious adverse reactions, the Data and Safety Monitoring Board (DSMB) confirmed the drug was safe and authorised the start of recruitment activities for Phase lll.
The three trial site teams (Manhiça Health Research Centre (CSIM) in Mozambique, Bahir Dar University (BDU) in Ethiopia, and KEMRI in Kenya) presented ongoing progress on the Phase III. The number of participants positive for hookworm infections has already been met and the teams will now focus on reaching the targets for the other two helminths: whipworm (T. trichiura) and threadworm (S. stercoralis). “We hope to finish collecting data by July of this year, and start with the analysis,” says Alejandro Krolewiecki, who is leading the clinical trial.
The two-day meeting also reviewedthe upcoming post-trial activities, including the molecular analysis of samples in KEMRI with support from the Leiden University Medical Center (LUMC). In fact, a few days before the meeting, the partners from LUMC visited the laboratories at Kilifi, Kenya, in preparation for the qPCR analysis that will take place there.
Steven Doyle, expert on genome-wide approaches and anthelmintic resistance at Sanger Institute, presented, together with ISGlobal and University of Leon researchers, the strategy – and challenges- for assessing anthelmintic resistance using samples from the STOP trial.
The final part of the meeting focused on preparing for the final nine months of the project. Regulatory activities (in charge of Liconsa Laboratories) and the submission of the clinical trial dossier to the European Medicines Agency (EMA) were discussed, as well as the dissemination and advocacy activities aimed at achieving public health impact.