Phase 1 Clinical Trial of TB Drug Candidate TBA-354 Discontinued

More investment is needed to expand the portfolio of new TB drug candidates

March 11, 2016

NEW YORK, NY (March 11, 2016)—TB Alliance has announced that it has stopped the clinical development program for the tuberculosis (TB) drug candidate TBA-354. This follows the voluntary hold it placed on the Multiple Ascending Dose (MAD) Phase 1 study of TBA-354 in January 2016.

The MAD study, designed to test the tolerability and pharmacokinetics of ascending doses of TBA-354 in healthy volunteers, resulted in side effects in the initial cohort.  Based on the observed side effects and pharmacokinetic data of TBA-354 generated in this cohort, TB Alliance together with its scientific advisors made the decision to stop the clinical trial and the clinical development program of TBA-354. 

“Observed toxicity was generally mild and all subjects have fully recovered, but the probability of this drug successfully advancing to the stage where it could become a component of a safe and effective novel regimen that would have a major impact on the global TB problem is too low to justify continued investment,” said Carl Mendel, MD, Senior Vice President, Research & Development, TB Alliance.

TBA-354 is a member of the nitroimidazole class of compounds. The Phase 1 program, which included a successful Single Ascending Dose study as well as the MAD study, was initiated in February 2015 and was halted in January 2016. TBA-354 was the first new TB drug candidate to move into Phase 1 since 2009, and its discontinuation underscores the dearth of early-stage clinical TB drug candidates in the pipeline.

“The results of the Phase 1 TBA-354 trial remind us that attrition and risk are inherent to research and development, and therefore it’s important to constantly replenish the reservoir of new drug candidates advancing into the global pipeline,” said Dr. Spigelman. “Today, we need to drive investment in TB drug research to dramatically increase the number of candidates entering clinical development.”

Tuberculosis is the world’s leading infectious disease cause of death, taking the lives of 1.5 million people each year. Shorter, simpler, and improved treatments are critical to achieving TB control and stopping the global pandemic.