STEP2C Stage 3 builds on earlier clinical trials conducted as part of the Pan-African Consortium for the Evaluation of Antituberculosis Antibiotics (PanACEA). The aim of STEP2C Stage 3 is to test the safety, pharmacokinetics and efficacy of new drug combinations with alpibectir (AlpE) in an innovative Phase 2b platform.
Pharmaceutical company GSK, whose active substance alpibectir (AlpE) is being investigated as an ethionamide booster, is also involved in the study, which aims to enroll a total of 120 adult participants at several clinical trial sites in Africa.
Ethionamide is an antibiotic used to treat tuberculosis when standard drugs are no longer effective due to resistance. Until now, ethionamide has had to be taken in very high doses, which often lead to severe side effects such as nausea and vomiting. Many patients therefore discontinue treatment. Thanks to ethionamide boosters, this situation may change. The aim of current research is to enhance the activity of ethionamide with alpibectir so that lower doses are sufficient and treatment is better tolerated.
Alpibectir has already been evaluated as generally well tolerated in previous Phase 2a studies conducted over 14 days in patients with drug-sensitive pulmonary tuberculosis. In the STEP2C Stage 3 study currently underway, alpibectir will be tested for a period of two months in combination with established first-line therapies, followed by continuation of standard therapy.
"With the evaluation of Alpibectir, UNITE4TB is testing its fifth novel drug candidate in its innovative phase IIb regimen selection platform, where we evaluate how novel assets are best combined with other licensed or new drugs. This approach will help to derisk the chance of progressing the wrong combination into phase III. LMU Hospital is proud to be the sponsor of a trial for such a promising drug.“ Prof. Dr. med. Michael Hoelscher, Director of the Institute of Infectious Diseases and Tropical Medicine at LMU Hospital, Principal Investigator of the STEP2C Stage 3 study and Scientific Director of UNITE4TB.
About UNITE4TB
UNITE4TB brings together 30 partners from 13 countries with the aim of fundamentally improving the development of new tuberculosis treatment regimens through innovative trial designs, adaptive platform-trial approaches, and more efficient clinical processes.
Funding
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101007873. The JU receives support from the European Union's Horizon 2020 research and innovation program and EFPIA, Deutsches Zentrum für Infektionsforschung e. V. (DZIF), and Ludwig-Maximilians-Universität München (LMU). EFPIA/AP contribute to 50% of funding, whereas the contribution of DZIF and the LMU University Hospital Munich has been granted by the German Federal Ministry of Education and Research.
