Even when a person’s tuberculosis is responding well to treatment, patients still experience side effects and must undergo a lengthy medication regimen. Typically, a person with TB can expect to be dosed with 3-4 different drugs over a period of at least six months. Better solutions are needed, and the UNITE4TB project have just launched a brand-new clinical trial that will test 14 combinations of nine existing drugs as well as two newly-developed candidate drugs.
The Phase 2B/C clinical trial takes place in Cape Town, South Africa, and tests multiple drug regimens and durations of treatment to find the best results. The research team will be searching for the right combination of drugs and the shortest possible treatment duration.
Developing completely new drugs is essential to overcome the increasing multidrug-resistant TB around the world, so the trial is examining the efficacy of two brand-new agents, GSK-656 and BTZ-043 in combination with with bedaquiline and delamanid which represents a totally new combination / regimen.
While current TB clinical trials usually focus on developing one drug at a time, a major advantage of the UNITE4TB trial is that it is investigating an entirely new drug regimen. According to Dr Wandini Lutchmun of the LMU University Hospital Munich, Germany, this could revolutionise the way TB drug development is done, and according to Prof. Martin Boeree, UNITE4TB project coordinator from Radboud University Medical Centre, the partnership “sets a new standard in this regard”.
UNITE4TB is the largest public-private partnership on TB drug development in the history of the European Union. Within the framework set out by the Innovative Medicines Initiative, it aims to develop a new system for trialling TB drugs in phase II clinical trials. It will upgrade current clinical trial methodology as well as enhancing the efficiency with which new regimens are delivered.
UNITE4TB is supported by the Innovative Medicines Initiative (IMI) programme, a partnership between the European Union and the European pharmaceutical industry.