The Global Alliance for TB Drug Development (TB Alliance), a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB,  has started the first human trial of a new tuberculosis (TB) drug candidate, designated TBA-354. It is the first new TB drug candidate to begin a phase 1 clinical trial since 2009.

“There is a critical gap of new compounds for TB,” said Mel Spigelman, MD, president and CEO of TB Alliance. “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.

TBA-354 emerged from studies designed to identify a next generation nitroimidazole for TB. TB Alliance conducted the studies in collaboration with the University of Auckland and University of Illinois-Chicago. Once identified, TB Alliance further advanced TBA-354 through pre-clinical development and is now the sponsor of the phase 1 study.

In preclinical studies, TBA-354 demonstrated more potent anti-bactericidal and sterilizing activity compared to pretomanid. Recruitment is under way to enroll nearly 50 US volunteers for the randomized, double-blind phase 1 trial, which will evaluate the safety, tolerability, pharmacokinetics, and dosing of TBA-354.

The World Health Organization 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.