MMV’s ‘Challenge Model’ creates a buzz in Australia

Innovative approach to accelerate development of antimalarials impresses Australian media

16 Sep 2013

Prof. James McCarthy, QIMR Berghofer Medical Research Institute, Queensland, Australia, and volunteer Jo Samford, have been interviewed by the Australian Broadcasting Corporation, on their work on the ‘Challenge Model’ that is being used to accelerate the development of new medicines for malaria.

The ‘Challenge Model’, developed by MMV in partnership with scientists at QIMR Berghofer, is an innovative new model that enables testing of promising candidate antimalarial drugs in healthy people inoculated with a small number of malaria parasites, without putting actual malaria patients at risk. These closely monitored volunteers are then given a trial drug to see how well it works in treating the disease. If it does not kill parasites sufficiently well, they are given a proven medicine before they get sick.

In traditional drug development, new medicines are first trialled in healthy volunteers to determine their safety (called a Phase I study) then tested in patients to determine if they actually cure the disease (efficacy; Phase II). By using the new model, efficacy can be determined at the same time as safety, cutting years off the R&D process. It means we need to test the drug on fewer patients sick with malaria, and that we can collate more data at a lower cost and progress to large-scale clinical trials quicker. Speed and cost are critical factors in the development of new, affordable medicines for malaria.

 “The human challenge model is a short-cut to getting experimental malaria drugs into the field, thereby assisting in the effort to reduce the burden of malaria,” said James. “The very standardised nature of the model means that we can also begin to compare drugs, to choose the winners earlier and to help match drugs to form the best combination regimens.”

“I’m delighted to see the Challenge Model, as well as the scientists and volunteers behind it, getting well-deserved recognition,” said Dr David Reddy, CEO of MMV. “A huge amount of work has gone into the development of this innovative tool that has the power to accelerate research of much-needed medicines for malaria. We will be able to get next-generation antimalarials to people sooner. This is an exciting prospect.”

Qld volunteers take part in malaria human trials. ABC News.
Human volunteers essential cog in malaria drug test. ABC Radio PM with Mark Colvin