University of Auckland (New-Zealand) researchers were crucial in the development of
a potential tuberculosis drug that is the first to advance to Phase one
clinical trial in six years. In New York today, the TB Alliance announced the start of the first
human trial of the new tuberculosis (TB) drug candidate, designated
TBA-354.
It is the first new TB drug candidate to begin a Phase one clinical trial since 2009.
TBA-354 emerged from studies designed to identify a next generation
nitroimidazole compound for TB. The TB Alliance conducted the studies in
collaboration with the University of Auckland and University of
Illinois-Chicago.
“Our chemistry team has worked on this since 2006 when the TB
Alliance approached us to help with this project,” says Professor Bill
Denny, director of the Auckland Cancer Society Research Centre and a
Principal Investigator of the Maurice Wilkins Centre at the University
of Auckland. “We made several hundred compounds, from which TBA-354 was
selected for clinical development in 2011.”
“It’s very pleasing for us to see this drug go all the way through to
Phase one clinical trial,” he says. “It’s a validation of our work
designing this compound to create a new and improved drug for the
treatment of tuberculosis.”
A group of five researchers from the University of Auckland has
worked on the project, with the chemistry led by Associate Professor
Brian Palmer.
Once identified, the TB Alliance further advanced TBA-354 through
pre-clinical development and is now the sponsor of the Phase 1 study.
“The TB Alliance approached us to do this work because of our
expertise in this particular chemistry that we developed in our cancer
research work,” says Professor Denny. “We are now working on another
drug development project with the TB alliance.”
The President and CEO of the TB Alliance, Dr Mel Spigelman says:
“There is a critical gap of new compounds for TB. The advancement of
TBA-354 into clinical testing is a major milestone, not only because of
the potential it shows for improving TB treatment, but because it is the
first new TB drug candidate to begin a Phase 1 clinical trial in six
years.”
TBA-354 comes from the nitroimidazole class of chemicals, known for
being effective against drug sensitive and drug-resistant tuberculosis.
The class also includes the experimental TB drug pretomanid (formerly
PA-824), which is being tested as a component of other novel regimens in
multiple clinical trials.
In preclinical studies, TBA-354 demonstrated more potent
anti-bactericidal and sterilising activity compared to pretomanid.
Recruitment is under way to enrol nearly 50 US volunteers for the
randomised, double-blind Phase 1 trial, which will evaluate the safety,
tolerability, pharmacokinetics, and dosing of TBA-354.
The World Health Organisation reported that 1.5 million people die
each year from TB, and more than nine million were diagnosed with the
disease. The lack of short, simple, and effective treatments is a
significant obstacle to TB control. However, because there is little
economic incentive to develop new tools, there are not enough promising
drugs in the pipeline, which could hinder efforts to develop the
appropriate treatments needed to combat the TB epidemic.
The Global Alliance for TB Drug Development (TB Alliance) is a
not-for-profit organization dedicated to finding faster-acting and
affordable drug regimens to fight tuberculosis (TB). Through innovative
science and with partners around the globe, it aims to ensure equitable
access to faster, better TB cures that will advance global health and
prosperity.
For media enquiries email s.phillips@auckland.ac.nz