Geneva – The World Health Organization (WHO) today issued its first report addressing a significant lack of medication and diagnostic tools for invasive fungal diseases, demonstrating the urgent need for innovative research and development (R&D) to close these GAPs.
Fungal diseases are an increasing number of public health concerns with common infections such as candida, which causes thrush in the oral and vagina, making them increasingly resistant to treatment. These infections disproportionately affect patients with severe illnesses and those receiving cancer chemotherapy, as well as those living with HIV and receiving organ transplants.
“Invasive fungal infections threaten the lives of the most vulnerable people, but countries lack the necessary treatments to save lives,” said Dr Nakata, deputy director of Interim Antibiotic Resistance AD. “Not only is the new antifungal and diagnostic pipeline inadequate, but also local hospitals are ineffective for fungal testing in low- and middle-income countries. This diagnostic gap means that the cause of people’s suffering remains unknown, making it difficult to get the right treatment.”
Fungi in the top “critical priority” category of the WHO Fungal Priority Pathogen List (FPPL) is fatal, with mortality rates reaching 88%. Advances in treatment mean that more people are likely to live in immunocompromised states. This could mean an increase in cases of invasive fungal disease. This is a complex challenge to manage for slow and complex R&D processes for new treatments due to the inaccessibility of diagnostic tools and limited availability of antifungal drugs.
Constraint processes in developing treatments for fatal fungal infections
The WHO report on antifungal drugs highlights that over the past decade, only new antifungal drugs have been approved by regulatory authorities in the United States, the European Union or China. Currently, nine antifungal drugs are under clinical development for use against the most health-threatening fungi, as detailed in FPPL.
However, only three candidates are in Phase 3, the final stage of clinical development. In other words, there is little expectation to be approved within the next 10 years. The 22 drugs are in preclinical development and are insufficient to supply the clinical pipeline, taking into account the dropout rates, risks and challenges associated with the early development stage.
Current issues of antifungal therapy include serious side effects, frequent drug drug interactions, limited drug forms, and the need for long-term hospital stays. The report highlights the urgent need for safer antifungal drugs and may reduce the requirements for ongoing drug monitoring.
Antifungal drugs are also needed to act against a wide range of severe infections caused by fungal preferential pathogens. Children, in particular, have few and no reliance on clinical trials exploring formulations tailored to pediatric administration and age.
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We recommend investing in global surveillance, expanding financial incentives for drug discovery and development, funding basic research to identify new minor targets for drug fungi, and investigating treatments that work by enhancing the immune response of patients.
Landscape report on the diagnosis of fungal-preferred pathogens
New diagnostic reports show that while commercially available tests for fungal preferential pathogens exist, these rely on well-equipped laboratories and trained staff. All countries, particularly LMICs, require faster, more accurate, cheaper and simpler testing on a wide range of fungal preferential pathogens, including diagnostic tools that can be used at point-of-care.
Existing antifungal diagnosis presents many challenges. They only work with a limited range of fungi, are inadequate precisely, and take a long time to get results. Most tests are less suitable for primary and secondary health care facilities, as certain diagnostics require stable power supply within a properly equipped laboratory.
Healthcare workers often have insufficient knowledge about fungal infections, but also have limited ability to perform the tests needed to determine the appropriate treatment, as they have the effect of growth in which fungi is more resistant to treatment. Those seeking to strengthen global responses to invasive fungal diseases and antifungal resistance are also developing an implementation blueprint for FPPL.
