Breakthroughs Blog: Medicines

Fungi have existed for hundreds of millions of years, long before dinosaurs walked the Earth, but fungal infections have become a rapidly growing challenge for human health in recent decades.Fungal diseases affect more than 300 million people each year, disproportionately impacting people in low-resource settings and those with weakened immune systems, including people living with HIV, cancer patients, and transplant recipients. Most fungal infections affect superficial tissue like the skin, nails, or hair and can cause chronic illness and productivity loss. Though less common, invasive fungal infections can spread throughout the body and are associated with high mortality.Why fungal diseases are becoming harder to ignoreThe rising incidence of fungal infections is driven by a variety of factors, including conflict, poverty, urbanization, pollution, travel, and climate change, which increase exposure, heighten vulnerability, and expand the reach of dangerous fungal pathogens. At the same time, advances in medicine mean more people are living longer with conditions that weaken the immune system, increasing the number of people at greater risk. Growing antifungal resistance is also making infections harder to treat and further limiting already scarce treatment options.Despite the mounting burden, fungal disease remains underprioritized, underdiagnosed, under-surveilled, and underfunded, making it one of the world’s most neglected global health threats.Why innovation is falling behindFungal infections receive less than 1.5 percent of all infectious disease research and development (R&D) funding, contributing to sparse pipelines for both therapeutics and diagnostics. Closing these gaps will require greater investment in R&D, particularly for tools designed for resource-constrained settings and targeting the pathogens that pose the greatest threat to human health. Stronger regulatory and procurement systems and international collaboration will also be essential to ensure emerging tools are affordable and accessible worldwide.Despite persistent gaps, several promising innovations demonstrate the potential for R&D to transform the global response to fungal disease.Promising advances in antifungal treatmentThere are currently only four classes of antifungal medicine available, many of which are associated with serious side effects or require lengthy, hospital-administered treatment courses. The pipeline of new antifungal therapies also remains thin.The World Health Organization (WHO) reported last year that only nine antifungal therapies were in clinical development to address WHO’s designated top four priority pathogens, including three in Phase 3 development. Although the Phase 3 trial for one of those candidates has since been terminated, another candidate, olorofim, developed by Shionogi and F2G, recently reported positive Phase 3 trial results. If approved, it could become the first antifungal treatment with a novel mechanism of action for that infection in more than 20 years.Earlier-stage research is also yielding promising advances. Researchers recently discovered that an antibiotic could target a priority fungal pathogen by switching it back from its invasive form to a less harmful form. This antibiotic could help existing antifungal drugs target dangerous fungal pathogens, allowing lower, less toxic doses of those drugs to be used.Together, these advances offer hope of a new generation of antifungal therapies.The future of fungal diagnosticsDiagnostic tools for critical fungal pathogens exist but with significant limitations, including invasive sampling requirements, long turnaround times, limited pathogen coverage, and inadequate sensitivity. Many also depend on sophisticated laboratories and highly trained staff, making them difficult to deploy in resource-constrained settings globally that bear a disproportionate burden of fungal disease.The MycoMEIA® assay developed at Johns Hopkins University and commercialized by Pearl Diagnostics represents a recent advance in antifungal diagnostics. The test received US Food and Drug Administration clearance in 2025. It uses a urine sample, which is much simpler and less invasive for patients than current options, and provides results in just a few hours.Another promising research development illustrates where fungal diagnostics may be headed next. Researchers at the Mayo Clinic and Zepto Life Technology recently reported early results from a new diagnostic platform that was able to identify 18 different fungal pathogens with a single test. While still in development, such approaches could not only streamline diagnosis for health care providers and patients, but also reduce costs and resource requirements, making them well-suited for resource-constrained settings.Closing the innovation gap Fungal diseases and antifungal resistance are attracting greater international attention, but the response still lags behind the scale and pace of this growing threat. Increased investment in the R&D of fit-for-purpose innovations, paired with stronger regulatory and health systems and global coordination, will be crucial to ensure new diagnostics and treatments emerge from the pipeline and reach the patients who need them most. 

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.

Last week, the US Food and Drug Administration (FDA) approved Moderna’s flu vaccine for older adults, making it the first licensed mRNA flu shot. The approval follows objections raised by FDA earlier this year that put the future of the application in question. Compared to traditional influenza vaccines, mRNA vaccines can be produced much more quickly, allowing public health experts to wait longer before selecting strains to target for the upcoming flu season, increasing the likelihood that the vaccine will match the strains actually circulating. Beyond regular flu season, faster vaccine production and the approval of this seasonal shot could help speed up the development and approval of a pandemic flu vaccine. FDA specifically issued a standard approval for the vaccine for adults between 50 and 64 and an accelerated approval for adults 65 and older—Moderna has agreed to do a post-licensure trial to gather more data on effectiveness in this group. The company expects some doses will be available ahead of the upcoming flu season. The results of a Phase 3 clinical trial published in the New England Journal of Medicine last week showed that a once-weekly oral HIV treatment maintained viral suppression as effectively as a standard daily treatment regimen, pointing to a potential new treatment alternative for people living with HIV. This option could increase convenience for patients taking daily pills and doesn’t require the regular clinical visits associated with long-acting injectable options, especially for patients who experience stigma or have other health conditions requiring treatments to manage. The study regimen consisted of a once-weekly combination tablet containing islatravir and lenacapavir, which was evaluated in adults whose HIV had remained suppressed for at least six months through a daily regimen across 12 countries. The first participant has been dosed in a first-in-human trial of Moderna’s vaccine candidate against Bundibugyo, the strain of Ebola behind the deadly ongoing outbreak in the Democratic Republic of the Congo, which has now become the second-largest Ebola outbreak in history. There are currently no vaccines or treatments available for Bundibugyo Ebola. The vaccine candidate, mRNA 1469, uses Moderna’s mRNA platform, which is also used in the company’s COVID-19 vaccine. The Coalition for Epidemic Preparedness Innovations (CEPI)-supported trial is being conducted at three Canadian sites among healthy adult volunteers to assess the safety and tolerability of the candidate and evaluate immune response. If the vaccine candidate successfully advances to approval, Moderna has committed to working with CEPI to urgently make doses available to low- and middle-income countries at accessible prices.

Last week, the Merck-Wellcome joint venture Hilleman Laboratories announced that it will manufacture doses of a promising vaccine candidate for the Bundibugyo strain of Ebola, which is behind the worrying outbreak in the Democratic Republic of the Congo. There are no specific vaccines or treatments available for Bundibugyo, so global partners have worked rapidly to advance candidates into testing since the declaration of the outbreak. Hilleman Laboratories will manufacture doses of IAVI’s single-dose vaccine candidate, which uses the same vaccine platform as Merck’s approved vaccine for the more common Zaire strain of Ebola and has been identified by the World Health Organization as the most promising candidate currently in development. The lab expects to be able to produce tens of thousands of doses to be used in early-stage trials, potentially by the end of this year. Alveo Technologies is partnering with the University of Texas Medical Branch to develop a molecular point-of-care diagnostic test for Lassa fever, a hemorrhagic illness endemic in parts of West Africa for which access to laboratory testing is limited. Improving access to reliable, point-of-care testing could greatly improve Lassa control in endemic regions, as well as limit its potential to spread more widely—the virus has been designated as a dangerous pathogen with pandemic potential. The diagnostic test will be evaluated at clinical sites in Nigeria and Sierra Leone. The partners are also collaborating on field testing of Alveo’s diagnostic platform for avian influenza surveillance in Peru. The Global Antibiotic Research & Development Partnership (GARDP) announced last week that the Thai Food and Drug Administration has approved zoliflodacin, a first-in-class, single-dose, oral antibiotic for gonorrhea treatment, marking the drug’s second global approval. Zoliflodacin, developed as part of a public-private partnership between GARDP and Innoviva Specialty Therapeutics, was approved earlier this year by the US Food and Drug Administration. Beyond the potential of this innovative treatment to help address the rising global threat of antibiotic resistance, the rapid follow-up approval of the drug beyond the high-income market also represents an important step toward ensuring expedited global access to innovative new antibiotics.