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Anti Tuberculosis Agent BTZ-043 commences Clinical Phase II

Since mid-November TB patients have been treated for the first time with the new substance BTZ-043 in Cape Town, South Africa.

The study is being conducted in the PanACEA consortium in collaboration with the TASK Applied Science Clinical Research Center, the University of Cape Town Lung Institute (UCTLI) and the Radboud University Medical Center and is being carried out under the sponsorship of the Ludwig-Maximilians-Universität (LMU) Munich, represented by Prof. Michael Hoelscher.

This is a randomized, controlled, phase Ib/IIa study to evaluate the safety, tolerability, Pharmacokinetics, drug-drug interaction and bactericidal activity of BTZ-043 administered orally once daily over 14 days to participants with newly diagnosed pulmonary tuberculosis. The primary objective is to assess the safety and tolerability of BTZ-043 given over 14 days by evaluation of adverse events during treatment and follow-up period in patients with newly diagnosed, uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis. In mid-November 2019, the first tuberculosis patients for treatment with BTZ-043 were included in the study. First results on tolerability and efficacy are expected by the middle of next year.

BTZ-043 was first discovered at the Leibniz Institute for Natural Product Research and Infection Biology, Hans-Knöll-Institut (HKI). It is also effective against highly resistant strains of tuberculosis, which is the most common cause of death worldwide caused by bacterial infections. The consortium InfectControl 2020 and the German Center for Infection Research (DZIF) support most of the studies as well as the Thüringer Aufbaubank for API development effort.

HAPILA undertook complete synthesis development for the tested API as well as its cGMP manufacturing, according to the Guideline of Good Manufacturing Practice, Part II – API (Manufacturing, Verification and Release). A Phase I study conducted in Germany showed good tolerability of BTZ-043. If BTZ-043 proves to be safe and effective in the current study (Phase II), this would be a major step in the development of a new drug.