(RTTNews) - BioVersys AG (BIOV) has announced that the first patient has been dosed in its Phase 2b clinical trial of AlpE for pulmonary tuberculosis, marking a key milestone in the company's collaboration with GSK and the UNITE4TB consortium.
Tuberculosis (TB) remains one of the world's deadliest infectious diseases, caused by Mycobacterium tuberculosis. Despite existing treatments, drug resistance is a growing challenge, with multidrug-resistant TB showing treatment success rates of only about 71%. AlpE (Alpibectir), a small molecule from Bioversys's TRIC platform, is designed to boost the activity of the antibiotic ethionamide, potentially overcoming resistance and reducing side effects.
The Phase 2b study will enroll up to 390 adults with drug-sensitive pulmonary TB across six African countries. Patients will receive AlpE in combination with Rifampicin, Pyrazinamide, and Ethambutol for two months, followed by 18 weeks of Rifampicin and Isoniazid.
The trial aims to evaluate efficacy, safety, and pharmacokinetics, with results expected by the end of 2027.
AlpE has already shown promising results in earlier Phase 2a studies, including bactericidal activity comparable to Isoniazid, and was generally well tolerated. The compound has received orphan-drug designation from both the U.S. FDA and the European Medicines Agency, providing incentives such as market exclusivity.
BioVersys also plans to initiate a Phase 2 trial of AlpE in TB meningitis in the first half of 2026, further expanding its potential role in tackling resistant forms of the disease.
BIOV has traded between CHF 21.20 and CHF 36.60 over the past year. The stock is currently trading at CHF 23.00, down 0.43%.
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