Auckland contributes to TB drug development

Auckland contributes to TB drug development

University of Auckland 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 One 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.

The University of Auckland’s commercial arm, Auckland UniServices Limited (UniServices), has managed the collaboration between TB Alliance and ACSRC from the outset.

“We’re delighted to see the achievement of this important milestone for ACSRC and TB Alliance. The ACSRC has an amazing track record of their novel drugs reaching the clinical trial stage and it’s fantastic to see that trend continue,” says Andrew Palairet, business development manager at UniServices.

ENDS

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