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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.