R&D Portfolio Update February 2019: DNDi Mycetoma programme

 

DNDi aims to deliver:

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

 

Mycetoma patients sitting in front of a hospitalDNDi’s current mycetoma portfolio includes:

 

ResearchDiscovery

 

  • MycetOS: In February 2018, the Mycetoma Open Source (MycetOS) project was launched by the University of Sydney, Erasmus MC, and DNDi to use an ‘Open Pharma’ approach to discover compounds that could lead to new treatments for patients suffering from fungal mycetoma (eumycetoma). MycetOS will progress drug discovery efforts through community-driven, in-kind scientific contributions and a robust, fully transparent online presence. All ideas and results will be published immediately in real time to an open-access database. Results and the associated data form the starting point for the MycetOS community, which communicates on Twitter (@MycetOS) and uses a dedicated subreddit forum for transparent interactive discussion, and github for sharing data and key project files.

 

Development

   Development

    One project in the development phase:

 

  • Fosravuconazole: In March 2017, the Mycetoma Research Centre (MRC), a WHO Collaborating Centre, in Khartoum, Sudan, began recruiting patients into the first-ever double-blind, randomized clinical trial for eumycetoma (fungal mycetoma). The clinical trial, which will recruit 138 patients, is studying the efficacy of weekly treatment with the anti-fungal fosravuconazole in moderate-sized lesions in comparison with the standard of care, 400mg of itraconazole daily, over 12 months of treatment.

    Fosravuconazole, an orally bioavailable azole developed for onychomycosis by Eisai Ltd (Japan) that is also under development by DNDi for Chagas disease, could be an effective and affordable treatment for eumycetoma. Its pharmacokinetic properties are favourable, and its toxicity is low.

    Following slower than anticipated recruitment, a protocol review and amendment was conducted in 2018 to extend the inclusion criteria in relation to lesion size and site, and age range of participants. By January 2019, 84 patients had been enrolled, reaching the threshold for interim analysis. This analysis will determine which of two treatment arms will be retained for the remainder of the trial (200mg vs 300mg of fosravuconazole weekly). 

 

 

Photo credit: Neil Brandvold-DNDi