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TB treatment Evaluation of a novel TB drug (SQ109) to shorten and simplify TB treatment The Pan African Consortium for the Evaluation of Antituberculosis Antibiotics (PanACEA) has the aim to explore new drugs that have the potential to shorten TB treatment. In this context, 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, and has sucessfull passed phase I studies in humans. The University of Munich is acting as the sponsor for the planned clinical trials to assess Background and problem addressed for the Evaluation of Antituberculosis Antibiotics (PanACEA), University of Munich (LMU) is responsible for the Although some progress has been made development of SQ109, which is currently in recent years in controlling tuberculosis entering clinical phase 2 testing. (TB) globally, TB has remained a persistent SQ109 is an orally active, small molecule, problem in the developing countries of chemotherapeutic agent developed Africa and Asia. TB is currently one of by Sequella Inc., a U.S.-based biotech the top three killer infectious diseases, company. It was shown to be active against and there is more TB in the world today microorganisms than at any other of the genus time in history. The Mycobacterium, current standard The PanACEA - SQ109 including M. TB treatment takes tuberculosis, in in 6 months to be project explores the vitro and in vivo completed, resulting studies. These studies in a high rate of potential of a new anti-TB demonstrated that defaulters and thereby SQ109 is at least treatment failures. drug to shorten TB tenfold more active Therefore, need for than ethambutol new anti-TB drugs treatment (EMB) against with the potential to M. tuberculosis. shorten treatment is Unlike EMB, SQ109 felt. is synergistic with rifampicin (RIF) and isoniazid (INH), and active against Currently, there are only a few novel drugs latent M. tuberculosis. Extensive tissue in the preclinical or early clinical pipeline (TMC207, PA-824, OPC-67683, and SQ109). distribution, a prolonged half-life, and animal infection model data suggest that In the context of a Pan African Consortium 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, which will be the sites to conduct the planned trials. Project Coordinator Dr Michael Hoelscher, Sonja Henne, Clincal Study Coordinator, and Dr Norbert Heinrich, Sponsor Medical Expert Michael Hoelscher Michael Hoelscher Project at a glance Official title Evaluation of a novel TB drug (SQ109) to shorten and simplify TB treatment Acronym PanACEA - SQ109 Project Coordinator Michael Hoelscher Department for Infectious Diseases and Tropical Medicine, Klinikum of the University of Munich (LMU), Germany Participants • Alimuddin Zumla, United Kingdom • Andreas Diacon, South Africa • Rodney Dawson, South Africa • Kheertan Dheda, South Africa • Martin Grobusch, South Africa • Gavin Churchyard, South Africa • Leonard Maboko, Tanzania • Andrea Rachow, Tanzania • Ayola Akim Adegnika, Gabon • Peter Mwaba, Zambia • Michael Ramharter, Gabon • Ulrich Mansmann, Germany • Gary Horwith, USA Total budget € 7,729,080 EDCTP budget € 4,959,070 Project duration 60 months Start date 16 June 2009 End date 15 June 2014 EUROPEAN COMMISSION Supported by the EU DG Research For more information EDCTP The Hague T +31 70 344 0880/0897 F +31 70 344 0899 E [email protected] I www.edctp.org SQ109 has the potential to shorten the duration of treatment, simplify the treatment regimen to once or twice per week, and decrease disease recurrence, particularly when infection is caused by M. tuberculosis strains with decreased susceptibility to INH and/ or RIF. Study design NIMR-Mbeya Medical Research Programme, the Tanzanian partner site, and Phase I studies in healthy its mobile laboratory individuals have been University of Munich is acting within the completed; SQ109 was well tolerated by EDCTP-funded PanACEA consortium (Pan study subjects. African Consortium for the Evalutaion of Antituberculosis Antibiotics), which Phase II studies will be conducted by comprises three European universities and University of Munich, Sequella Inc. and the twelve African partner sites. In addition to seven African partner sites in the scope SQ109, PanACEA is currently conducting of this project. Partner sites are situated the phase III REMox trial for the evaluation in South Africa, Zambia, Tanzania and of moxifloxacin, and phase II evalutation of Gabon. Planned phase II studies include high-dose Rifampicin (HIGHRIF). assessment of Early Bactericidal Activity of SQ109 in monotherapy and in combination with RIF over 14 days, which will be done in EDCTP relevance South Africa. This consortium is committed to develop capacity for TB trials in Africa, and continue In the subsequent study, SQ109 will be performing trials testing new TB regimens. tested as part of a four drug regimen The aim, in concordance with EDCTP replacing Ethambutol during intensive objectives, is to shorten and simplify TB phase treatment, led by the seven partner. treatment, which will contribute to reduce the burden of TB globally. 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. The EBA study is planned to commence in the middle of 2010, the following study is scheduled for mid 2011.