R&D Portfolio Update March 2018: DNDi Mycetoma programme

 

DNDi aims to deliver:

  • A new safe, effective and affordable treatment for patients with eumycetoma.

 

DNDi’s current mycetoma portfolio includes:

 

Women from the research staff testing drugs

Development

   Development

    One project in the development phase:

 

  • Fosravuconazole: After receiving regulatory and ethical approval in March 2017, the Mycetoma Research Centre (MRC), a WHO Collaborating Centre, began recruiting patients into the first-ever double-blind, randomized clinical trial for eumycetoma (fungal mycetoma). The clinical trial, which plans to recruit 138 patients, is studying the efficacy of the anti-fungal fosravuconazole in moderate lesions in comparison with the current treatment, itraconazole. Fosravuconazole, which is an orally bioavailable azole that is under development for Chagas disease, could also be an effective and affordable treatment for eumycetoma. Its pharmacokinetic properties are favourable and its toxicity is low. The primary objective of this single-centre study being conducted in Sudan is to demonstrate the superiority of fosravuconazole over itraconazole after 12 months’ treatment.

    By the end of 2017, 20 patients had been enrolled into the trial; this number was lower than the target of 48 patients by this time, mainly due to stringent protocol restrictions. There is a planned protocol review and amendment in 2018 to extend the inclusion criteria concerning lesion size, age range, and lesion site. 

    A great deal of capacity building took place in 2016 and 2017 to prepare the MRC for the trial, including training and upgrading of infrastructure. On 20 July 2017, the Upgraded Research Unit (RU), set up by the Mycetoma Research Centre with support from DNDi, was officially opened in Khartoum, Sudan. The RU consists of male and female patient wards, a research laboratory and a pharmacy.

 

 

 

 

Photo credit: Abraham Ali/Imageworks-DNDi