New drug substance BTZ-043 for tuberculosis
View this video marking the start of the UNITE4TB phase IIb/c clinical trial programme, which kicked off at the trial site in Cape Town, South Africa (active content from YouTube is only loaded and personal data is only transferred to YouTube when this video is called up; more information in our privacy policy).
Since 2014, DZIF scientists are developing a promising antibiotic for tuberculosis, which has also proven to be effective effective against multidrug-resistant pathogens in preclinical tests. The new drug substance BTZ-043, a Benzothiazinon, showed good tolerability in a Phase I study conducted in Germany. The tuberculosis antibiotic is at an advanced stage of clinical testing.
Background
Tuberculosis is the most common cause of death worldwide caused by bacterial infections. According to the World Health Organization (WHO), approximately 1.5 million people die from tuberculosis every year, particularly in Southeast Asia, Africa and the Western Pacific region. An enormous challenge in the treatment of tuberculosis is the increased incidence of resistant pathogens against which only a few antibiotics are still effective. The WHO is, therefore, placing great hopes in the development of drugs based on new chemical entities. BTZ-043, a benzothiazinone, is such a new drug candidate.
BTZ-043 was discovered at the Leibniz Institute for Natural Product Research and Infection Biology - Hans Knöll Institute (Leibniz-HKI) in Jena. Since 2014, the new chemical entity has been developed in a consortium of scientists from the Leibniz-HKI and the Tropical Institute at the Hospital of the LMU Munich within the framework of the German Center for Infection Research (DZIF) and InfectControl. The study is funded by the German Federal Ministry of Education and Research (BMBF) and the European and Developing Countries Clinical Trials Partner-ship (EDCTP), and the Bayerisches Staatsministerium für Wissenschaft und Kunst and the Thüringen. The further preclinical and clinical development has been carried out within the framework of the IMI consortium UNITE4TB (Academia and Industry United Innovation and Treatment for Tuberculosis) since June 2021.
Development
Following the start of the clinical trials in Cape Town in 2019, further studies on tolerability (Phase Ib) and efficacy (Phase IIa) were conducted at the DZIF. The aim of the further development of BTZ-043 in international research teams is to find effective combination partners. Usually, a combination of three to four drugs is used to prevent resistance.
Which combination of medication, which dosage and which duration of therapy is the right one is being investigated both within the framework of the European-African PanACEA consortium and in phase II clinical trials within UNITE4TB. The principal investigator is Prof Dr Michael Hoelscher from the Tropical Institute of the LMU Hospital.
