Sparks - BioVersys

BioVersys has announced the first patient dosing in a Phase IIb trial evaluating alpibectir in combination with ethionamide (AlpE) for the treatment of drug-susceptible pulmonary tuberculosis (TB). The study is being led by partner GSK, which is developing alpibectir in TB under a 50:50 partnership with BioVersys, and is being conducted within the UNITE4TB consortium, a public–private partnership. The trial is taking place across six African countries and will assess AlpE in combination with three first-line TB drugs (rifampicin, pyrazinamide and ethambutol) in drug-susceptible TB patients for two months, followed by standard therapy alone (rifampicin and isoniazid) for an additional 18 weeks. The study will evaluate efficacy, safety and pharmacokinetics, with top-line results expected by end-2027.

The programme builds on an earlier Phase IIa open-label, 14-day study (ENABLE trial) assessing AlpE alongside first-line TB therapy, with top-line data anticipated in Q226. AlpE, developed through BioVersys’ TRIC platform in collaboration with GSK, aims to enhance the activity of ethionamide and overcome resistance mechanisms. BioVersys also plans to initiate a Phase II study in TB meningitis in H126.