Mycetoma Development

 

  • Target disease: Mycetoma
  • Main partners (since project start): 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.
  • Project start: September 2015
  • Funding (since project start): Bill & Melinda Gates Foundation, USA; Department for International Development (DFID), UK; Dutch Ministry of Foreign Affairs, (DGIS).

 

Overall Objective:

  • Conduct a randomized controlled clinical trial to investigate the efficacy of fosravuconazole (E1224) 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.

Protocols of the phase II/III aiming at assessing the comparative efficacy, safety, and tolerability of fosravuconazole in patients with eumycetoma caused by Madurella mycetomatis.were finalized in 2016 and recruitment of patients (with a target of 136 participants) should start early 2017. An interim analysis will be conducted at three months.

DNDi is currently preparing for a Phase II/III randomized controlled trial that 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-blind, randomized, single-centre study will be to demonstrate superiority of fosravuconazole over itraconazole after 12 months’ treatment in patients with eumycetoma caused by Madurella mycetomatis.

 

Last update: February 2017