In December 2015, DNDi published the latest version of its project portfolio that was approved by its Board of Directors. This is the first portfolio resulting from DNDi’s new dynamic portfolio approach as developed in our new Business Plan (2015 – 2023). New projects entered into the portfolio for mycetoma and hepatitis C, two disease areas with significant unmet patient needs. A new chemical entity for visceral leishmaniasis also entered the pre-clinical phase.
Mycetoma is a potentially devastating slow-growing bacterial or fungal infection, which can develop into a chronic infection of the skin tissues. The currently available treatments for the fungal form, eumycetoma, are expensive, ineffective, and have serious side effects. Patients often have to undergo amputations. A randomized controlled trial will be conducted to study the efficacy of fosravuconazole compared to the current treatment.
Transmitted through exchange of body fluids, mostly through exposure to contaminated blood, chronic hepatitis C remains silent for a long time. Most are unaware of their infection. While 15% to 20% of people clear their infection naturally, others develop chronic infection and, over time, chronic liver disease. New direct-acting antiviral drugs (DAAs) for HCV have revolutionized the therapeutic landscape: they are much more effective, safer, and better tolerated than existing therapies. However, access to these treatments is quite limited mostly because of the high price charged by innovator pharmaceutical companies. Middle-income countries with the highest burden of disease have been excluded from access programmes that focus on least-developed or low-income countries. DNDi and the Ministry of Health of the Government of Malaysia recently signed a memorandum of understanding to work together to develop a public health approach to Hepatitis C within the framework of the future National Strategic Plan on viral hepatitis. The immediate goal is to conduct clinical studies of promising new treatment regimens for Hepatitis C, to be followed by scale-up of treatment for patients, with the overall objective of ensuring equitable access to affordable and effective treatments for patients suffering from this disease in Malaysia. Clinical studies will be launched later this year in multiple sites, with DNDi and Clinical Research Malaysia (CRM), a non-profit company owned by the Ministry of Health, as the co-sponsors.
The visceral leishmaniasis portfolio has been expanded recently with the nomination of the new chemical entity DNDi-0690 as a pre-clinical candidate. This compound, previously identified from the nitromidazole backup programme, demonstrates good efficacy in vivo, and an acceptable toxicity evaluation.