BioVersys Initiates Phase 2b Trial for AlpE in Tuberculosis Treatment

BioVersys AG has announced the first patient dosing in a Phase 2b clinical trial for AlpE, a potential new treatment for drug-susceptible pulmonary tuberculosis (TB). Under a collaboration with GSK, the trial is part of the larger UNITE4TB project. The study aims to evaluate the efficacy and safety of AlpE in combination with standard TB drugs over a two-month period followed by additional treatment. Results from this trial are anticipated by the end of 2027.

The trial, sponsored by the Institute of Infectious Diseases and Tropical Medicine, is conducted in six African countries. BioVersys also plans to start a Phase 2 trial for TB meningitis later in 2026.

AlpE, derived from BioVersys’ TRIC platform, has already shown promise in earlier phases and received orphan-drug designations in both the U.S and Europe. The drug aims to enhance the effectiveness of existing TB drugs and overcome resistance. This effort seeks to address the persistent global challenge of TB, especially in high-burden countries.