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AnTBiotic – progressing TB drug candidates to clinical proof of concept

Obiettivo

Tuberculosis (TB) today rivals HIV/AIDS as the leading cause of death from infectious diseases. The number of TB patients has never been higher and the growing proportion of drug-resistant TB is threatening control strategies both in the developing and developed world, Eastern Europe being a particularly worrying point in case. The anTBiotic consortium aims to fuel the long-term TB clinical pipeline while immediately offering new options to clinicians when confronted with multidrug-resistant (MDR)-TB. More specifically, the proposed studies aim to:

a) Establish the proof of concept of anti-TB efficacy in humans of a pioneering, first-in-class, low-dose GSK oxaborole clinical drug candidate;
b) Identify a combination of β-lactam antibiotics suitable for the treatment of MDR TB orally or as a once daily intravenous or intramuscular application and
c) Incorporate the best β-lactam combination into an explorative salvage regimen for untreatable patients with extensively drug-resistant TB

The anti-TB activity in humans will be established in a two-week EBA clinical studies that combine established (CFU, TTP) and new clinical markers (biomarkers, PET/CT). These datasets will help ascertain anti-TB efficacy in humans and generate confidence on their validity in longer-term drug combination trials. A variety of modelling approaches to predict optimal dosing will be used. Finally, we intend to use at least one of these novel anti-TB entities as part of a pioneering, non-controlled clinical trial in highly drug resistant subjects in Europe and South Africa. This final clinical intervention will hopefully be of immediate benefit to drug-resistant patients in the EU and elsewhere in addition to generating a strong precedent for further adoption worldwide.

Campo scientifico

Parole chiave

Programma(i)

Argomento(i)

Invito a presentare proposte

H2020-SC1-2016-2017

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Bando secondario

H2020-SC1-2016-RTD

Meccanismo di finanziamento

RIA - Research and Innovation action

Coordinatore

GLAXOSMITHKLINE INVESTIGACION Y DESARROLLO SL
Contribution nette de l'UE
€ 704 870,67
Indirizzo
C/ SEVERO OCHOA NUMERO 2 PARQUE TECNOLOGICO DE MAD
28760 TRES CANTOS MADRID
Spagna

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Regione
Comunidad de Madrid Comunidad de Madrid Madrid
Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Collegamenti
Costo totale
€ 704 870,67

Partecipanti (4)

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Ultimo aggiornamento: 8 Dicembre 2023

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Permalink: https://cordis.europa.eu/project/id/733079/it

European Union, 2024