Today, the World Health Organization (WHO) released its inaugural reports highlighting the significant shortage of medications and diagnostics for invasive fungal infections, underscoring the pressing requirement for groundbreaking research and development (R&D) to address these deficiencies.
Fungal diseases represent a rising challenge for public health, with widespread infections like Candida — responsible for conditions such as oral and genital thrush — becoming more difficult to treat over time. Such fungal ailments tend to affect critically ill people and those whose immune systems are compromised, encompassing individuals receiving cancer treatments, persons diagnosed with HIV, and recipients of organ transplants.
Invasive fungal infections pose significant threats to those who are most at risk, yet nations do not have access to the necessary treatments to prevent fatalities," stated Dr. Yukiko Nakatani, Acting WHO Assistant Director-General for Antimicrobial Resistance. "The development of new antifungal medications and diagnostic tools is inadequate, and there is also a critical shortage of fungus tests in low- and middle-income regions, including local hospitals. The absence of these diagnoses leaves patients' conditions undiagnosed, complicating efforts to provide appropriate care.
Fungi listed under the 'critical priority' category of the World Health Organization's Fungal Priority Pathogens List (FPPL) can be lethal, with fatality rates as high as 88%. With improvements in treatment options, an increasing number of individuals may live with compromised immune systems, potentially leading to higher incidences of invasive fungal infections. Managing this issue is complicated by the lack of accessible diagnostic equipment, insufficient supplies of antifungal medications, and a sluggish, intricate research and development process for developing novel therapies.
Restricted procedures in crafting therapies for lethal fungal ailments
The WHO's report on antifungal medications points out that over the last ten years, just four novel antifungal treatments have received approval from regulatory bodies in the USA, the EU, or China. The document also notes that nine antifungal agents are currently undergoing clinical trials for their potential effectiveness against the deadliest fungal pathogens, as outlined in the FPPL.
Nonetheless, only three candidates have reached Phase 3, which is the last part of clinical testing, indicating that very few approvals should be anticipated over the coming ten years. Currently, twenty-two medications are still undergoing preclinical studies; this count appears inadequate for sustaining a robust clinical pipeline when accounting for the high failure rates and various hurdles encountered during initial developmental phases.
Issues with current antifungal treatments include serious side effects, frequent drug-drug interactions, limited dosage forms and the need for prolonged hospital stays. The report highlights the urgent need for safer antifungal medicines, possibly reducing requirements for continuous drug monitoring.
Medicines that combat a broad spectrum of serious infections caused by fungal priority pathogens are essential. There is a particular lack of resources for children, as very few clinical studies have been conducted to determine appropriate pediatric doses and suitable formulations for different ages.
WHO recommends investing in global surveillance, expanding financial incentives for drug discovery and development, funding basic research to help identify new and unexploited targets on fungi for medicines, and investigating treatments that work by enhancing patients’ immune responses.
Diagnostic landscape analysis for high-priority fungal pathogens
The new diagnostics report shows that while commercially available tests exist for fungal priority pathogens, these rely on well-equipped laboratories and trained staff, which means that most people in in low- and middle-income countries (LMICs) do not benefit from them. All countries, but particularly LMICs, need faster, more accurate, cheaper and easier testing for a broad range of fungal priority pathogens, including diagnostic tools that can be used at or near point-of-care.
Many issues exist with current antifungal diagnostic methods; these techniques can only identify a narrow spectrum of fungi, lack sufficient accuracy, and have lengthy result times. Additionally, most testing procedures are unsuitable for use in basic and intermediate healthcare settings since some diagnoses necessitate reliable power sources and specialized laboratory conditions.
Health workers often have insufficient knowledge about fungal infections as well as the impact of fungi growing more resistant to treatments, resulting in limited ability to perform the testing needed to determine the appropriate treatment. WHO calls for strengthening the global response against invasive fungal diseases and antifungal resistance, and is also developing an implementation blueprint for the FPPL.
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