46 million reasons and more to celebrate

WHO’s recently released World Malaria Report revealed that the global case load of malaria remains high at 247 million cases a year, almost 3% of the global populace. An estimated 619,000 people are dying from the disease each year. Given the backdrop of challenges faced, brought on by the Triple Cs of conflict, climate change and COVID, combined with a widening funding gap, these numbers could have been higher. Thankfully, the remarkable commitment of national malaria control programmes, supporting partners, including MMV and funders, to expand the use of malaria control and prevention measures meant that as a community we were able to ‘hold the line’ against the disease.

In one example, the extraordinary success in expanding seasonal malaria chemoprevention (SMC) meant that a staggering 46 million children were protected from malaria this year alone. To paraphrase Javier Hourcade Bellocq, a member of the Global Fund Board, that alone is 46 million reasons to celebrate!

Perspectives on the future role of SMC were expanded following the publication of results of a study combining SMC with the RTS,S malaria vaccine. The study showed significantly better efficacy for the combination than for either intervention alone. Reinforcing this “belt and braces” approach, Phase I/IIB results were reported for the new R21 vaccine. Highly promising reductions in infections were achieved, on a background of SMC use and insecticide-treated bed net use.

Beyond SMC, MMV’s continued commitment offered more reasons to celebrate in 2022. Artemisinin combination therapy (ACT) Pyramax® (pyronaridine-artesunate) was included in the WHO Malaria Treatment Guidelines with a strong recommendation for broader use. Given increasing concerns about antimalarial drug resistance in Africa, this long-sought approval is a vital step forward.

Another milestone worth celebrating this year was the decision to progress the non-artemisinin combination ganaplacide-lumefantrine to Phase 3 clinical trials, based on the highly promising efficacy reported in the Phase IIb trial. If all goes to plan, this novel combination therapy for both adults and children will offer not only a once-daily alternative to current malaria treatments, but also an alternative to ACTs should they succumb to artemisinin resistance.

Resistance was never out of the news this year and culminated in the November launch of the WHO antimalarial drug resistance strategy for Africa in a bid to stop its spread. In addition to recognising the importance of new tools like Pyramax and ganaplacide-lumefantrine, the strategy highlights interest in approaches such as multiple first-line treatments (MFT), designed to reduce drug pressure on ACTs. MMV has long been an advocate and catalyst for MFT approaches, including our support for pilots of this approach in Kenya and Burkina Faso beginning in 2021. 

Meanwhile, additional combinations such as MK5717-pyronaridine and ZY19489-ferroquine, which include new molecules chosen for their activity against resistant strains, are progressing through the pipeline. Other highly promising molecules which have recently entered testing in human subjects include MMV533, which is completing studies in the human volunteer infection study model and GSK701, which recently completed Phase I studies. These compounds are all fasting-acting and have single-dose potential.

COVID brought to the fore the larger issues of diversity, equity and inclusion in the areas of health care and access to tools and technologies. Our work to discover, develop and facilitate access to antimalarials to cure and protect the world’s most marginalised and under-served populations spans these important issues. MMV’s strategy has a strong focus on vulnerable populations at highest risk of malaria complications – most importantly pregnant women and children.

MiMBa, or Malaria in Mothers and Babies, is a core element of MMV’s strategy developed to address the needs of pregnant women and girls. The recent inclusion of artemether-lumefantrine in the WHO Treatment Guidelines will bolster the number of women protected from malaria while in their first trimester. A key pillar of this work was the meta-analysis of the data, which was supported in part by MMV. To gather data that might help further expand the range of malaria treatment options for pregnant women, MMV and partners have established the MiMBa Pregnancy Registry, which is currently underway in Kenya and Burkina Faso.

Dedicated to ensuring equitable access to antimalarial tools, MMV has also worked hard to diversify the supply of targeted quality medicines. In support of the call for drug production closer to where it is needed most and were thrilled to have worked with Kenya's UCL become the first African manufacturer to gain WHO prequalification of SP in 2022, that will help protect pregnant women. And that is just the beginning. We are working with two further companies in Nigeria to emulate UCL’s success and rounded off the year on a high note by signing a memorandum of understanding with Africa CDC focused on strengthening African manufacturing of malaria medicines.

Continuously seeking greater diversity and inclusivity in the world of malaria science and research, we worked with partners to expand capacity within clinical trial teams in Africa by supporting the training of young researchers in the PAMAfrica consortium. In addition, we are working to launch the first-ever Phase I trial in Africa next year of a paediatric antimalarial at Ifakara Health Institute in Tanzania.

Another moment of celebration was when the Australian Therapeutics Goods Agency approved single-dose tafenoquine for the radical cure of P. vivax malaria in children aged 2 years and over. Every new paediatric antimalarial is precious. The concomitant deployment of tafenoquine and quantitative G6PD testing has been evaluated in Brazil for the past 18 months via the landmark MMV-backed TRuST study. The next step is for the country’s Ministry of Health to evaluate the evidence and make a policy decision for nationwide rollout.

In summary, despite the challenges encountered in 2022, we’ve had plenty of reasons to celebrate and we are ever grateful for the support and guidance of our Board, donors and partners that have brought us to this juncture. We also recognize the increasing challenge of securing adequate funding to progress our partnership pipeline and maximize its impact moving forwards. In this regard, it was heartening to see that the Global Fund replenishment raised USD15.7 billion for the next 3 years through increased commitments and an expanded donor base that included malaria-endemic countries. We applaud and thank all who committed to ensuring that the critical work the Global Fund continues.

Global health is currently in troubled waters, and the only way out is through. To achieve a malaria-free world, WHO highlights the importance of building resilient health systems as well as ensuring there is a robust research and development pipeline of new tools. We at MMV are committed to playing our part to get back on track. With continued support from our donors and partners, we will vigorously pursue our mission to assure that high-quality affordable malaria medicines are discovered, developed and delivered to those who need them. While pursuing the end of malaria will not be an easy path, it is the right path, and we are already well on the way.