R&D MODEL & PORTFOLIO
PROJECT START: September 2015 OVERALL OBJECTIVE: Conduct a randomized controlled clinical trial to investigate the efficacy of fosravuconazole compared to the current treatment, itraconazole.
Treating eumycetoma is a challenge. Currently, the antifungals ketoconazole and itraconazole are the only therapies available but these are expensive, ineffective, and have serious side effects. Patients often have to undergo amputation, and often more than once, sometimes resulting in death. Safe, effective antifungal agents that are appropriate for use in rural settings are urgently needed. Fosravuconazole (E1224), an orally bioavailable azole that is under development for Chagas disease, may be an effective and affordable treatment for eumycetoma. Fosravuconazole, a prodrug, is rapidly converted to ravuconazole, which has been shown to have potent in vitro activity against one of the causative agents of eumycetoma, Madurella mycetomatis. Its pharmacokinetic properties are favourable and its toxicity is low. A randomized controlled trial will be conducted with the WHO Collaborating Centre on Mycetoma in Khartoum to study the efficacy of fosravuconazole in moderate lesions in comparison with the current treatment, itraconazole. The primary objective of this double-blinded, randomized, singlecentre study (with an interim analysis at three months) will be to demonstrate superiority of fosravuconazole over itraconazole after 12 months treatment. The study is due to begin in 2016.
MAIN PARTNERS: Eisai Co. Ltd, Japan; Erasmus Medical Center, The
Netherlands; Radboud University Medical Center, Nijmegen, The Netherlands; Mycetoma Research Centre (MRC), Soba University Hospital, Khartoum, Sudan; Institute of Endemic Diseases (IEND), Khartoum University, Sudan
Mustafa Alnour Alhassan, a young university student aged 26, with mycetoma, sitting on the rickshaw he took to the Mycetoma Research Centre (MRC) in Khartoum, Sudan. Despite the treatments he received, the flesh-eating fungal disease continued to progress and his leg was amputated in July 2015. The disease unfortunately spread to his groin and lungs. He died in March 2016.
52 › DNDi Annual Report 2015