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TB drug candidate advances to phase 1 trial; first since 2009
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Enrollment has begun for the first phase 1 clinical trial of a tuberculosis drug candidate since 2009, according to a press release.
The new drug, TBA-354, is a pyridine-containing biaryl compound from the nitroimidazole class of chemicals. The upcoming human trial is sponsored by the Global Alliance for TB Drug Development (TB Alliance), which conducted pre-clinical studies in collaboration with the University of Auckland and University of Illinois-Chicago.
A previous study of TBA-354 published in Antimicrobial Agents and Chemotherapy demonstrated antibactericidal and sterilizing activity in vitro and in vivo. The early results are similar to delamanid and superior to pretomanid, two other experimental nitroimidazole chemicals currently in phase 3 clinical trials.
Mel Spigelman
“There is a critical gap of new compounds for TB,” Mel Spigelman, MD, president and CEO of TB Alliance, said in the release. “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 6 years.”
The study will recruit 50 U.S. volunteers for a randomized, double blind trial that will evaluate safety, tolerability, pharmacokinetics and dosing of the experimental drug.
Reference:
Upton AM, et al. Antimicrob Agents Chemother. 2014;doi:10.1128/AAC.03823-14.