Breakthroughs Blog: Malaria

Recently published results from a large multi-country study found that pooled tuberculosis (TB) testing could greatly reduce costs and boost access to diagnosis. Access to the gold standard of rapid molecular testing is limited—only just over half of people diagnosed with TB in 2024 were first tested using the technology. Instead, they were diagnosed using older technology, which can take weeks to produce results, during which the infection could progress or be transmitted to others. Millions of additional individuals with TB go completely undiagnosed. A major contributing challenge is that rapid molecular testing requires an expensive diagnostic cartridge for each sample. Pooled testing involves testing samples from multiple individuals with one cartridge. Patients are only retested individually if the result is positive. Unlike new diagnostic technologies, like AI-enabled portable X-ray machines, that are promising but would require additional funding to implement, pooled testing could be scaled up rapidly without new funding because it utilizes technologies that many labs already have.Medicines for Malaria Venture (MMV) is advancing the novel, first-in-class antimalarial compound, cabamiquine, into the next stage of clinical development, with the hope that the compound could be part of a single-dose, long-acting treatment for the prevention and treatment of malaria, which could greatly simplify care compared to current options. Cabamiquine was discovered by researchers at the University of Dundee, with financial and scientific support from MMV, and then advanced by Merck to proof of concept. Recently published results from two Phase 2a trials showed that a regimen of cabamiquine and pyronaridine was able to clear uncomplicated Plasmodium falciparum malaria in more than 90 percent of participants and demonstrated a strong safety profile. MMV will now lead Phase 2b clinical development of the compound. The Biomedical Advanced Research and Development Partnership (BARDA) recently announced that it has awarded Scynexis a $214 million contract for the development of an antifungal to treat and prevent invasive fungal infections, the less common but more serious form of fungal infection that penetrates deep into the tissues of the body. Fungal infections are a growing global challenge, but there is a significant gap in the pipeline of new tools to address them. Last year, the company reported positive findings from a Phase 1 trial of an oral dose of the candidate and is currently conducting a Phase 1 trial of an intravenous formulation. The award includes initial funding to advance the company’s antifungal candidate into Phase 2 trial, with an option for additional, longer-term funding. 

Last week, Gilead Sciences announced that it has expanded the scope of its voluntary licensing agreements with six manufacturing partners, who are already manufacturing the recently approved twice-yearly lenacapavir for HIV prevention, to include investigational once-yearly lenacapavir. Following the unprecedented Phase 3 trials for twice-yearly lenacapavir, an ongoing Phase 3 trial is evaluating a once-yearly option that could provide a full year of prevention with just one annual dose, further expanding prevention options and addressing persistent barriers to uptake and adherence. Establishing these agreements at this early stage helps manufacturers, regulators, health systems, and communities prepare for the broad, rapid, and equitable scale-up of the once-yearly option, if it is eventually approved. The World Health Organization (WHO) has updated its malaria guidelines to include Coartem® Baby, the first antimalarial developed specifically for newborns and young infants weighing between two and five kilograms. This patient group previously had no medicine specifically designed for their unique needs, leaving them to be treated with modified doses of formulations intended for older children, raising the risk of treatment failure or toxicity. The drug was developed by Novartis and partner Medicines for Malaria Venture (MMV), with financial support from the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency. WHO’s inclusion of Coartem® Baby in the guidelines informs and enables malaria-endemic countries to introduce the treatment in national malaria programs, supporting broader access. After receiving prequalification by WHO and approval from Swiss and Ghanian regulatory authorities, Coartem® Baby has so far been rolled out in 11 countries. The Coalition for Epidemic Preparedness Innovations (CEPI) recently announced that it is awarding $3.9 million to support research projects aimed at improving understanding of the Bundibugyo ebolavirus behind the ongoing outbreak in the Democratic Republic of the Congo. Specifically, the funding will support modelling and analytic teams led by the Institut National de Recherche Biomédicale, Imperial College London, and Makerere University School of Public Health. These teams will collect, integrate, and analyze outbreak data to guide the outbreak response; inform the design of fast, efficient vaccine clinical trials; and support longer-term preparedness against similar outbreaks in the region. To ensure long-term applicability, the partners have placed a strong emphasis on capacity strengthening and open sharing of data and methods, so that the tools and knowledge these projects generate can be utilized in future outbreaks in the region. 

Last week, Cepheid announced that its Xpert Hemorrhagic Fever Panel test has received Emergency Use Listing from the World Health Organization, enabling the technology to be deployed to help identify suspected cases and support outbreak containment in the rapidly growing outbreak of Bundibugyo Ebola in the Democratic Republic of the Congo. The molecular panel test detects and identifies Ebola virus (multiple strains, including Bundibugyo), Crimean-Congo hemorrhagic fever, Marburg virus, and Lassa virus, providing results in around an hour. The test runs on Cepheid’s GeneXpert diagnostic technology system, which is already widely used across Africa, helping enable rapid implementation. Cepheid previously donated an initial shipment of tests cleared by the US Food and Drug Administration through the Department of War, and the new listing now enables further deployment. A Phase 2 clinical trial led by the Serum Institute of India found that an experimental monoclonal antibody for dengue virus was safe, well-tolerated, and provided evidence of efficacy in a Phase 2 clinical trial. Dengue affects more than 200 million people each year and is a growing global threat due to the expanding range of the virus-carrying mosquito species. There are several licensed vaccines for dengue but no licensed antiviral drugs. The experimental antibody previously neutralized all four serotypes of dengue virus in animal studies and demonstrated safety in a Phase 1 trial in healthy adults. Researchers at the National Institutes of Health (NIH) have discovered rare antibodies that could inform the development of a therapeutic or preventive intervention for alpha-gal syndrome, an emerging tick-bite-associated condition behind a growing number of cases in the United States and globally, which can lead to allergic reactions to a molecule in red meat and other animal products. The discovery was made through malaria research—the scientists were originally trying to find antibodies that could target alpha-gal (a sugar molecule) on malaria parasites as a potential strategy for malaria prevention. In laboratory tests, the rare antibodies successfully hindered human allergic antibodies from binding to red meat allergens. There are currently no specific treatments or preventions for alpha-gal syndrome.

Every year, World Mosquito Day brings renewed attention to mosquito-borne diseases like malaria. But attention is not enough. What matters now is whether we are using the tools we have effectively and whether those tools will still work tomorrow. Malaria drug resistance is not new. Until the early 2000s, chloroquine was the backbone of treatment. It was widely available and highly effective until resistance spread and treatments began to fail. Health systems were caught off guard, deaths rose, and the world learned a painful lesson: once resistance takes hold, recovery is slow, costly, and measured in lives lost. Today, we are seeing warning signs again. Resistance to existing first-line drugs is emerging in parts of East Africa, the Horn of Africa, Southeast Asia, and South America. At the same time, malaria deaths rose to 610,000 in 2024, up from 597,000 the year before, a trend unfolding against a backdrop of severe financing shortfalls. Global funding reached only $3.9 billion in 2024, less than half the $9.3 billion required. Sustained underinvestment has well-documented consequences: fewer preventive measures, overstretched health systems, and reduced capacity to respond when resistance emerges. The economic case for doing more is equally stark. According to a recently published analysis, reducing malaria cases by 90 percent by 2030 could increase Africa's GDP by $126 billion and expand global trade by $80.7 billion. Now urgency matters more than ever. We cannot afford to wait for existing tools to fail before acting. In the words of Dr. Brenda Akia, Africa representative and Vice Chair of the Committee on the United Nations Convention on the Elimination of All Forms of Discrimination against Women: "Malaria was killing people even when the drugs were working. Now that the drugs are failing, we are cooked if we do not act fast." Cooked, mingled and served as gourmet food at the banquet where the mosquitoes will gather to celebrate their victory over humanity. This is not an exaggeration. The impact of chloroquine resistance—the memories of the increasing death tolls, the desperation to save lives with a tool that was becoming blunt— still lingers on. The response must be twofold. We need sustained financial commitment to ensure countries can procure and deliver existing tools through their health systems, and we need investment in new tools to stay ahead of resistance. Both are essential, and neither is optional. On the innovation front, there is encouraging progress. New medicines are advancing through development to better protect those most at risk. Through the work of Medicines for Malaria Venture and its partners, triple combination therapies designed to preserve the effectiveness of existing drugs are in development. In addition, ganaplacide-lumefantrine, a novel combination therapy developed with Novartis, has completed a Phase 3 trial with positive results. Looking ahead, long-acting injectable medicines that could provide protection against malaria for up to six months are also in development. Beyond new medicines, innovations in vector control are further strengthening the fight against malaria. These include new spatial emanator repellents that can provide protection for up to 12 months and dual-insecticide nets designed to combat insecticide resistance. Together, these advances reinforce our belief that ending malaria within a generation is within reach.However, as Brazil's Minister of Health Alexandre Padilha said recently, "Innovations that are not in the hands of those who need them are no good." As was done for the COVID-19 response, we must accelerate regulatory processes for innovations. Mechanisms must be put in place to make these critical innovations affordable and accessible. The health workforce must also be trained to deploy them effectively, and civil society organizations and community groups must also lead the way in raising awareness of the threat posed by drug resistance and the need for new tools. Countries are already showing leadership. For example, Thailand is strengthening its national strategy with a focus on surveillance and resistance response. Kenya is deepening community engagement. Rwanda is investing in stronger data systems. Uganda is supporting local manufacturing. These are concrete actions, not intentions. Countries have the capacity, but they need sustained and predictable financing to deliver new tools effectively. This is the moment for malaria elimination. Progress will not be secured by innovation alone, nor by financing alone, but by aligning both with strong country delivery systems. We call on the entire global health ecosystem to unite under one final “Big Push.” It is time to turn hope into well-funded action and finally take us across the finish line to a malaria-free world.