Progress on grants signed before 2010

Evaluation of a novel TB drug (SQ109) to shorten and simplify TB treatment (PanACEA - SQ109)

Project Coordinator: Dr Michael Hoelscher
Institution: Department for Infectious Diseases and Tropical Medicine, Klinikum of the University of Munich (LMU), Germany
Targeted disease: Tuberculosis
African countries involved: Gabon, South Africa, Tanzania, and Zambia
Cofunding partners: Bill & Melinda Gates Foundation (BMGF, USA), BMBF (Germany), Klinikum der Universität München, Institute for Medical Bioinformatics (Germany), Medical Research Council (United Kingdom), Netherlands Organisation for Scientific Research (NWO, Netherlands) and Sequella Inc. (USA),
Budget: € 6,012,526 (€ 1,136,761 EDCTP)
Status: Ongoing

This project is pursuing the phase II clinical development of SQ109, a novel anti-TB drug candidate that has demonstrated antimicrobial activity and synergies with standard anti-TB drugs in in-vitro and in-vivo studies. University of Munich is acting as the sponsor for the planned clinical trials to assess safety and efficacy of SQ109 in TB patients. The project is conducted in cooperation with Sequella Inc., the company who developed the molecule, and seven African partner institutions, providing the sites to for the clinical trials.

The phase I studies in healthy individuals have been completed; SQ109 was well tolerated by study subjects. Phase II studies will be conducted by University of Munich, Sequella Inc. and the seven African partner sites in the scope of this project. Partner sites are situated in South Africa, Zambia, Tanzania and Gabon. Planned phase II studies include assessment of Early Bactericidal Activity (EBA) of SQ109 in monotherapy and in combination with RIF over 14 days, which will be done in South Africa. These studies will assess the potential of SQ109 to shorten TB treatment as part of a regimen, and yield sufficient data to design a larger phase III trial, which is needed for approval of the drug by FDA and EMEA. On 07 December 2010, the first participant was enrolled into this initial EBA study.