New clinical trials in the war against tuberculosis
An EU-funded public-private partnership launched in 2021 is fast-tracking the development of novel tuberculosis (TB) treatments. Called UNITE4TB, the project has now announced the start of its phase 2b/c clinical trial. The first participant has been enrolled at the project’s trial site in Cape Town, South Africa. According to the World Health Organization, TB was responsible for 1.3 million deaths worldwide in 2022 alone, making it the second biggest infectious killer after COVID-19. A major problem is that TB sometimes fails to respond to first-line drugs and requires longer and more toxic treatments, with patients having to take several drugs in combination for 6 months and sometimes even more. UNITE4TB is working towards new, shorter treatment regimens with fewer side effects that can fight all types of the disease.
Finding the best treatment
As reported in a recent press release, the project’s phase 2b/c trials will be testing 14 different combinations of nine existing drugs and two new drug candidates, GSK656 and BTZ-043. The best treatment combination identified in stage 2b will go through to stage 2c, during which more information will be collected on the treatment’s safety and how long it should be taken. The goal is to create regimens that will improve current multidrug-resistant treatments and also work on drug-sensitive TB. Prof. Michael Hoelscher of UNITE4TB project partner University Hospital of Munich, Germany, comments on the trial design: “There are three major steps in TB regimen development: the establishment of the optimal dose for each individual drug, the identification of the right combination of four different drugs and the shortest possible treatment duration of the regimen of choice. In UNITE4TB, we are addressing these aspects via the most efficient trial designs possible.”
Let the trials begin
Besides the South African trial site, where the first participant has been enrolled, clinical trials will also be held in other countries such as the Philippines, Tanzania, Uganda and Vietnam. The sites were all chosen based on TB prevalence. “Today’s announcement marks an exciting moment for TB research,” remarks Prof. Martin Boeree of UNITE4TB project coordinator Radboud University Medical Center, the Netherlands. “The world needs new drugs for TB but also new ways to run clinical studies. Our public-private partnership sets a new standard in this regard. If successful, our work will deliver a new treatment regimen of shorter duration that can be used to fight all types of tuberculosis.” UNITE4TB (ACADEMIA AND INDUSTRY UNITED INNOVATION AND TREATMENT FOR TUBERCULOSIS) is supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry. The project ends in 2028. For more information, please see: UNITE4TB project website
Keywords
UNITE4TB, tuberculosis, TB, clinical trial, drug, treatment, public-private partnership