Newsroom
UNITE4TB expands clinical trial program with STEP2C study
UNITE4TB is proud to announce the initiation of STEP2C, a new Phase 2b clinical trial that forms part of the UNITE4TB clinical trial program. The study focuses on the evaluation of novel treatment combinations for drug-susceptible tuberculosis (TB), with particular attention to isoniazid monoresistance and the need for bedaquiline-sparing regimens.
Building on earlier clinical work conducted within the PanACEA Consortium, STEP2C is designed to generate robust evidence on the safety, pharmacokinetics, and efficacy of promising new combinations within an innovative Phase 2b platform.
As part of UNITE4TB’s adaptive and data-driven approach to regimen selection, STEP2C will contribute to accelerating decision-making on which drug combinations should progress further in development. The trial will be conducted across multiple sites in Africa, leveraging established clinical trial capacity and strengthening collaboration across the global TB research community.
STEP2C is sponsored by UNITE4TB partner, the Institute of Infectious Diseases and Tropical Medicine at LMU University Hospital Munich. It reflects UNITE4TB’s mission to accelerate the development of shorter, safer, and more effective TB treatments through public-private collaboration.
The study includes contributions from GSK, also a UNITE4TB partner, and Bioversys, a biopharmaceutical company that, in collaboration with GSK, is evaluating the novel alpibectir-ethionamide (AlpE) regimen for pulmonary TB in combination with first-line TB drugs.
The first patient has now been dosed in the AlpE arm of the study, marking an important milestone for the STEP2C study and for global TB drug development efforts.
Read the full press release on first patient dosed in STEP2C