The Aurum Institute is pleased to announce the enrolment of the first participant in its clinical trial testing two host-directed therapies (HDTs) in patients with drug-resistant tuberculosis (DRTB-HDT). The milestone was reached by the study team at the Isango Lethemba TB Research Unit in Port Elizabeth, South Africa, under the direction of Dr Francesca Conradie. The DRTB-HDT study, which will ultimately enrol 330 participants at sites in South Africa, Mozambique, Romania, Moldova, and Georgia, is supported by the Horizon 2020 program of the European Commission. Additional support for one of the experimental therapies (CC-11050) has been provided by Amgen and Medicines Development for Global Health. Project partners in Belgium, Germany and Switzerland are involved in the laboratory work, statistics, monitoring, and management of the trial.
Tuberculosis has historically been the most common infectious cause of death globally, surpassed only briefly by Covid-19 during the recent pandemic. TB treatment with antibiotics is lengthy and often unsuccessful. Even if cured, most patients are left with permanent lung damage that causes disability and reduces survival.
The phase 2 DRTB-HDT trial will test two host-directed agents to see if they can improve long-term outcomes in TB. One, CC-11050, is a new anti-inflammatory agent that may help to promote recovery of lung function. The other is metformin, a drug used worldwide for the treatment of diabetes mellitus. Studies in animals suggest metformin may help speed the eradication of TB infection. Both HDTs will be given in addition to standard DRTB treatment. The experimental arms will be compared to a control arm receiving standard treatment alone. Participants in all 3 arms will undergo regular tests of sputum (to determine the progress of eradication of infection), breathing (to look at recovery of lung function), and blood (to monitor the safety of the treatments).
More information about the study may found at the project’s website, www.DRTB-HDT.org, or by contacting the sponsor directly at RWallis@Auruminstitute.org.