Africa-Europe partnership to launch Phase 3 clinical trial in early pregnancy

The Safety of Antimalarials in the First Trimester (SAFIRE) consortium, made up of scientific and social research experts in malaria in pregnancy, has kicked off the preparation of reportedly, the first-ever Phase 3 clinical trial testing the efficacy and safety of antimalarials in women in their first trimester of pregnancy.

 With financial support from the Global Health EDCTP3 Joint Undertaking (EDCTP3), a partnership funded by African and European countries as well as the European Union, and the Swiss State Secretariat for Education, Research, and Innovation (SERI), SAFIRE will generate robust evidence on the efficacy, safety and tolerability of antimalarials in the first trimester of pregnancy by conducting an adaptive platform trial and social research. 

“Its results will feed into policy and guidelines to ensure that women have optimal treatment options in early pregnancy. The enrolment of women in the trial will start in 2025 pending data from the MiMBa pregnancy registry and PYRAPREG studies,” informs the statement.

 Dr Hellen Barsosio, is one of the project’s scientific co-leads and a Research Scientist of maternal and newborn health at Kenya Medical Research Institute (KEMRI). 

The SAFIRE consortium, formed to address the evidence gap in the use of antimalarial drugs in early pregnancy, is coordinated by the Amsterdam University Medical Center, with scientific co-leadership by the University of Sciences, Techniques and Technologies of Bamako (USTTB) and KEMRI. The Phase 3b clinical trial is co-sponsored by Medicines for Malaria Venture (MMV) and the Liverpool School of Tropical Medicine (LSTM), who will provide scientific technical input. It will be the first Bayesian adaptive platform trial that assesses the efficacy, safety and tolerability of antimalarial treatments in the first trimester of pregnancy, a significant step for global health research.

The data generated by SAFIRE; which will begin in Burkina Faso, Kenya and Mali; will support the design of future trials targeting other infectious diseases, especially those that affect pregnant women in low- and middle-income