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Division of Microbiology and Infectious Diseases (DMID)

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Novel Therapeutic for Tuberculosis: SQ109

Tuberculosis (TB) is a contagious disease caused by the bacterium Mycobacterium tuberculosis. M. tuberculosis spreads through the air and usually attacks the lungs but can also affect other parts of the body. An estimated one-third of the world’s population has latent TB infection, which means that they do not have any symptoms but may later develop TB disease. The World Health Organization estimates that there were 12 million cases of TB in 2011, including 1.1 million cases among people with HIV. In 2011, TB claimed 1.4 million lives worldwide.

Treating TB can be difficult and complex. While some cases of TB can be cured with a combination of antibiotics that have to be taken for 6 to 12 months, current medications are becoming less effective against the disease as the problem of drug-resistant TB grows. New drugs and treatment regimens for TB are urgently needed.

Discovery and Development of SQ109 Holds Promise

In 1999, NIAID researchers discovered a novel antibiotic that later became known as SQ109. NIAID and the National Cancer Institute provided grants and preclinical services to Sequella, Inc., to further develop the drug. NIAID-funded contractors conducted both preclinical and clinical testing of SQ109, including drug interaction studies; animal safety and toxicity studies; tablet production; and Phase IB/IC clinical trials evaluating safety, tolerability, and pharmacokinetics.

These studies showed that SQ109 is effective against M. tuberculosis, including drug-resistant strains. Scientists also found that SQ109 boosts the activity of other TB drugs, suggesting that SQ109 could potentially be used in new treatment regimens against TB.

Evaluation and Possible Efficacy Against Other Microbes

Several studies are being planned to learn more about the safety and efficacy of SQ109. NIAID is supporting development of a Phase I clinical trial evaluating the cardiac safety of SQ109. Other research organizations are also supporting further clinical testing of SQ109 against drug-sensitive and multidrug-resistant TB all over the world. In addition, Sequella is evaluating the drug for possible therapeutic uses beyond TB, including Clostridium difficile and Helicobacter pylori.

Last Updated March 19, 2013