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TBnet Newsletter July 2021

1. TBnet is a partner in UNITE4TB, a newly launched large consortium for the development of novel tuberculosis treatment regimens

To advance anti-tuberculosis (TB) science and enable the progression of new, safe, and affordable treatment solutions for TB patients worldwide, a new consortium of 30 partners from 13 countries has officially launched. The 7-year, €185 million project called UNITE4TB, aims to accelerate and improve the clinical evaluation of combinations of existing and novel drugs, with the goal of developing new and highly active TB treatment regimens for drug-resistant and -sensitive TB.

UNITE4TB is the newest project of the IMI AMR Accelerator and the largest public-private collaboration on clinical TB drug development in the history of the EU. It will set a new standard for anti-TB regimen development, enhancing the efficiency with which new treatments are delivered to TB patients across the world.

With European Federation of Pharmaceutical Industries and Associations (EFPIA) and Associated Partners on board, UNITE4TB has access to the majority of the most innovative TB compounds, currently in late pre-clinical, clinical phase 1, and early phase 2 stage. The consortium will deliver an efficient, global clinical trials network equipped to conduct phase 2 trials. State-of-the-art adaptive trial designs will be implemented, and advanced modelling, artificial intelligence and machine learning techniques will be employed. All of this will allow for the selection and testing of novel combination regimens with a high probability of success in subsequent phase 3 clinical trials.

TBnet participates in the implementation and communication activities of UNITE4TB. The collaboration ensures dissemination of results directly to those countries where the incidence of tuberculosis is large (Central and Eastern Europe) and facilitates a linkage with local priorities and a translation of the result in context-specific TB treatment strategies. Using its strong education infrastructure, TBnet provides an ideal platform to engage professionals and researchers in UNITE4TB’s activities.

UNITE4TB has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101007873. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA, Deutsches Zentrum für Infektionsforschung e. V. (DZIF), and Ludwig-Maximilians-Universität München (LMU). EFPIA/AP contribute to 50% of funding, whereas the contribution of DZIF and the LMU University Hospital Munich has been granted by the German Federal Ministry of Education and Research.

Contributed by:

Irina Kontsevaya, PhD

Postdoctoral Researcher at Research Center Borstel, Germany

Chair in Diagnostics at TBnet

2. TBnet members are invited to join Pragmatic Optimized Rifampicin Trial, a new TBnet study

The project has been recently presented during the TBnet Spring Scientific Meeting. Now all TBnet members who have been interested in the project can join!

Pragmatic Optimized Rifampicin Trial (PORT): ‘Pragmatic trial on safety and tolerability of an optimized (high) dose of rifampicin in tuberculosis patients’.

Objective of the study: the primary objective is to describe and compare the incidence of hepatotoxicity in standard-of-care and in a regimen with 1800 mg rifampicin in patients with rifampicin-susceptible tuberculosis. We identified hypotheses for non-inferiority. The null hypothesis is that the regimen with an optimized (higher) dose of rifampicin is associated with more hepatotoxicity than the regimen with the standard dose. The alternative hypothesis is that there is no difference in hepatotoxicity between the regimen with an optimized (higher) dose of rifampicin and the regimen with the standard dose. In this case, the regimen with an optimized (higher) dose is non-inferior to the regimen with a standard dose of rifampicin.

Read the project draft and see the clarifying slides at the project space, TBnet website, you need to log-in to see the project space:

3. TBnet Annual Meeting 2021 will be online

Save the space for the Online TBnet Annual Meeting 2021!

The meeting is preliminary planned for the second week of October 2021 – between the ERS Congress and The Union Conference. There will be a number of important administrative and scientific activities – more information and program will follow in August and September.

4. TBnet supports the 4th Baltic Tuberculosis Symposium, August 25-26 – LTBI management and more – register for free

Prof. Christoph Lange and Dr Olena Rzhepishevska will, on behalf of TBnet, take part at the 4th Baltic Tuberculosis Online Symposium. The Symposium will cover four main topics in two days: latent TB infection management and treatment, pharmacovigilance, different approaches to patient-centered care and patients, and health care workers' wellbeing perspective.

The 4th Baltic Tuberculosis Symposium, August 25-26 is organized by Latvian WHO Collaborating Center for Research and Training in Management of Multidrug-Resistant Tuberculosis (WHO CC Latvia) of Riga East University hospital in collaboration with different partners from TB community in Europe. Many thanks to Dr. Liga Kuksa for this initiative!

We are happy to share with you the preliminary agenda and announcement of the Symposium: -

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