Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Tuberculosis: clinical trials on a newly developed drug initiated

06.06.2018

The first antibiotic against tuberculosis that has been developed in Germany is now ready for clinical testing. BTZ043, as the newly developed drug substance is called, is also effective against multidrug-resistant pathogens which are increasingly challenging successful treatment worldwide. Scientists from the Ludwig-Maximilians-Universität (LMU) Munich and the Leibniz Institute for Natural Product Research and Infection Biology – Hans Knöll Institute (HKI) in Jena are leading this project. The German Center for Infection Research (DZIF) and the InfectControl 2020 consortium are funding a major part of the trials.

The problem of antibiotic resistance has increased sharply over the last decades. Today, we face the challenge of having to manage a growing number of multidrug-resistant pathogens against which only a few antibiotics have remained effective.


Tuberculosis bacteria: (left) treated with BTZ043, holes develop in the mycobacterial cell walls; (right) untreated

Dr Andreas Wieser

In the case of tuberculosis, the situation is particularly difficult as the treatment regimen still includes several antibiotics which need to be taken simultaneously. Additionally, mycobacteria, which cause tuberculosis, have many mechanisms with which they protect themselves against specific effects of different antibiotics. Consequently, several new agents, ideally with different modes of action, are urgently needed to develop new treatment forms.

New site on mycobacteria targeted

BTZ043 is the first member of a newly discovered class of antibiotics and chemically belongs to the benzothiazinones. “The agent irreversibly binds to an enzyme that is needed for bacterial cell wall synthesis,” explains Dr Florian Kloß, Head of the Transfer Group Antiinfectives of InfectControl 2020 at the HKI.

“As the enzyme can then no longer function, holes develop in the mycobacterial cell walls and the cell contents drain out,” adds DZIF scientist Prof Michael Hoelscher, Director of the Department of Infectious Diseases and Tropical Medicine at the LMU Munich (also see image). “The agent targets tuberculosis bacteria highly selectively and consequently does not affect other bacteria.”

Clinical trial tests tolerance

Recruitment of the first trial subjects for clinical testing of BTZ043 can now be initiated, following the approval of the Federal Institute for Drugs and Medical Devices (BfArM) and the Bavarian Chamber of Physicians’ Ethics Committee.

Led by Prof Hoelscher, up to 40 volunteers will receive the antibiotic at the trial centre of the company Nuvisan in Neu-Ulm. Hoelscher explains the procedure, “We want to ensure that the drug is absorbed by the body and is well-tolerated. To this end, a very low single dose will be administered, and subsequently this dose will gradually be increased for the next trial volunteers.” The aim of the trial is to reach the dose which showed good efficacy in animal models. This dose is far below the highest dose that the animals still tolerated well.

United against infections

A team of scientists and businessmen is involved in the development of this new tuberculosis drug. The agent, BTZ043, was discovered at the HKI in Jena. Since 2014, the drug has been developed further at the DZIF and InfectControl 2020 and other sites in a collaboration project between the Medical Center of the LMU Munich and the HKI.

The HKI is responsible for precise investigations of absorption, distribution, metabolism and excretion as well as for developing analytical methods for detecting metabolites. As a funder, the LMU Munich’s Medical Center is responsible for preclinical and clinical development as well as for quality and safety of the drug. The substance will be produced at Hapila GmbH, a medium-size pharmaceutical company in Gera.

Financing the drug development costs of several million euros has been made possible though joint public and private funding. Particularly the two research alliances DZIF and InfectControl 2020 are involved in developing the active agent. They are being funded by the Federal Ministry of Education and Research.

Contact

Prof Michael Hoelscher
Department of Infectious Diseases and Tropical Medicine at the Medical Center of LMU Munich
T +49 89 2180 17613
E-mail: hoelscher@lrz.uni-muenchen.de

DZIF Press Office
Karola Neubert and Janna Schmidt
T +49 531 6181 1170/1154
E-mail: presse@dzif.de

Karola Neubert | idw - Informationsdienst Wissenschaft
Further information:
http://www.dzif.de

More articles from Health and Medicine:

nachricht Potential seen for tailoring treatment for acute myeloid leukemia
10.12.2018 | University of Washington Health Sciences/UW Medicine

nachricht UC San Diego researchers develop sensors to detect and measure cancer's ability to spread
06.12.2018 | University of California - San Diego

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Researchers develop method to transfer entire 2D circuits to any smooth surface

What if a sensor sensing a thing could be part of the thing itself? Rice University engineers believe they have a two-dimensional solution to do just that.

Rice engineers led by materials scientists Pulickel Ajayan and Jun Lou have developed a method to make atom-flat sensors that seamlessly integrate with devices...

Im Focus: Three components on one chip

Scientists at the University of Stuttgart and the Karlsruhe Institute of Technology (KIT) succeed in important further development on the way to quantum Computers.

Quantum computers one day should be able to solve certain computing problems much faster than a classical computer. One of the most promising approaches is...

Im Focus: Substitute for rare earth metal oxides

New Project SNAPSTER: Novel luminescent materials by encapsulating phosphorescent metal clusters with organic liquid crystals

Nowadays energy conversion in lighting and optoelectronic devices requires the use of rare earth oxides.

Im Focus: A bit of a stretch... material that thickens as it's pulled

Scientists have discovered the first synthetic material that becomes thicker - at the molecular level - as it is stretched.

Researchers led by Dr Devesh Mistry from the University of Leeds discovered a new non-porous material that has unique and inherent "auxetic" stretching...

Im Focus: The force of the vacuum

Scientists from the Theory Department of the Max Planck Institute for the Structure and Dynamics of Matter (MPSD) at the Center for Free-Electron Laser Science (CFEL) in Hamburg have shown through theoretical calculations and computer simulations that the force between electrons and lattice distortions in an atomically thin two-dimensional superconductor can be controlled with virtual photons. This could aid the development of new superconductors for energy-saving devices and many other technical applications.

The vacuum is not empty. It may sound like magic to laypeople but it has occupied physicists since the birth of quantum mechanics.

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

New Plastics Economy Investor Forum - Meeting Point for Innovations

10.12.2018 | Event News

EGU 2019 meeting: Media registration now open

06.12.2018 | Event News

Expert Panel on the Future of HPC in Engineering

03.12.2018 | Event News

 
Latest News

Small but ver­sat­ile; key play­ers in the mar­ine ni­tro­gen cycle can util­ize cy­anate and urea

10.12.2018 | Life Sciences

New method gives microscope a boost in resolution

10.12.2018 | Physics and Astronomy

Carnegie Mellon researchers probe hydrogen bonds using new technique

10.12.2018 | Life Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>