Malaria patients enter DNDi clinical trials

Geneva, Switzerland — 2 Jul 2004

Millions of people in developing countries still die from diseases neglected by drug development research. A year after its launch, the Drugs for Neglected Diseases Initiative (DNDi) is starting clinical trials for two fixed-dose drug combinations against malaria, and counts another seven projects in the pipeline for sleeping sickness, visceral leishmaniasis and Chagas disease.

“People suffering from tropical diseases are still taking drugs that are hugely toxic, or ineffective because of parasite resistance,” says Dr Bernard Pécoul, executive director of DNDi. “We have matched patients’ needs with opportunities in research and development, and are now working to push those candidate drugs through the development process all the way to the patients themselves.”

To ensure a balanced portfolio of drugs in the pipeline, DNDi mixes quick-fix with long-term projects. In the short term, DNDi is developing “fixed-dose” combinations (two drugs combined into one tablet) for uncomplicated malaria: artesunate/amodiaquine for use in Africa and artesunate/mefloquine for use in Asia and Latin America.

“Many anti-malarials have become virtually useless because of resistance,” explains Dr Jean-René Kiechel, the manager for DNDi’s Fixed-dose Artesunate Combination Therapy (FACT) project. “Most countries are now switching to the more effective artemisinin-based combination therapy (ACT). The challenge is now to provide ACT as fixed-dose combinations that are simple to use rather than separate tablets: it helps to ensure patients take their treatment properly and to prevent future resistance.”

DNDi starts clinical trials for the two new drug combinations in adult and child strengths this month in Burkina Faso and Thailand. The new drug combinations will be registered at the end of next year and available to patients as of 2006.

The initiative is also pushing for registration of the drug paromomycin for use against visceral leishmaniasis in Africa, and assessing the value of combining existing drugs to treat sleeping sickness. For the longer haul, DNDi is conducting basic “discovery” work to identify compounds that can block enzymes essential to parasites’ metabolism, in order to develop these into drugs.

DNDi’s strength lies in its collaborative model: using existing research and capacity for drug development in different parts of the world and pulling it together to build each project.

“It’s by pooling our resources and know-how that we can identify promising projects and move them forward quickly and at low cost,” explains Bernard Pécoul. “We are working to provide patients with treatments they desperately need, but we are also promoting collaboration and technology transfer between academic research institutes and drug developers across the world. Ultimately, we hope that means more and better treatments for patients in the future.”

For further information or to set up an interview with DNDi Executive Director Dr Bernard Pécoul, please contact Jaya Banerji, tel. 022 906 9234 or email jbanerji@dndi.org.