Sudan – Sudan is making significant strides in the battle against mycetoma, a chronic and disabling disease, with the introduction of a new oral treatment, fosravuconazole. This promising development was revealed in the results of the world’s first double-blind, randomized clinical trial, announced by the Drugs for Neglected Diseases initiative (DNDi) at the 13th European Congress on Tropical Medicine and International Health (ECTMIH) in Utrecht, Netherlands.
According to Africa Science News, the trial conducted in Sudan in collaboration with the Mycetoma Research Center (MRC) in Khartoum, Erasmus MC in the Netherlands, and Japanese pharmaceutical company Eisai Co., Ltd., demonstrated the safety, patient-friendliness, and effectiveness of fosravuconazole in treating the fungal form of mycetoma. Mycetoma, caused by either bacteria or fungi, is a neglected disease prevalent across Africa, Asia, and the Americas, with Sudan and Mexico reporting the highest cases globally. The disease, contracted through thorn pricks, often leads to severe deformities and disabilities, making effective treatment crucial.
Professor Ahmed Fahal of the University of Khartoum and MRC Director, highlighted the challenges in treating mycetoma, including expensive and often unavailable treatments with serious side effects. He emphasized the disease’s impact on poor populations in remote areas, typically field laborers and children. The 2017 clinical trial for fosravuconazole marked a significant step in finding an effective treatment for eumycetoma, the fungal form of the disease.
The trial results indicated that fosravuconazole and the standard treatment, itraconazole, had similar efficacy rates, with fosravuconazole showing an efficacy rate of 65% to 85% compared to itraconazole’s 80%. Despite not being statistically significant, fosravuconazole offers considerable advantages, including reduced pill burden and ease of administration, which is vital for patient adherence and convenience.
DNDi, along with its partners, has presented these results to Sudan’s National Medicines and Poisons Board. The Sudanese Ministry of Health has authorized the use of fosravuconazole under controlled conditions for mycetoma patients at the MRC, recognizing the public health importance of addressing this neglected disease. However, ongoing conflicts in Sudan pose challenges in accessing treatment.
Dr Kappei Tsukahara from Eisai expressed commitment to making fosravuconazole available to all who need it, acknowledging its potential to simplify fungal mycetoma treatment. DNDi and its partners are also working to assess the local treatment needs in key endemic countries and address the global knowledge gap about mycetoma.
The study, supported by various international organizations, represents a significant advancement in the fight against a disease that disproportionately affects vulnerable populations, offering hope for simpler and more effective treatment options.