Combining some of the latest breakthroughs in tuberculosis research with some of the oldest treatment options, the TB Alliance has launched a pivotal trial to test how well their four-drug regimen can treat tuberculosis in light of growing resistance to current therapies.
The not-for-profit is contributing an experimental compound, pretomanid, which represents a class of novel anti-bacterial agents called nitroimidazole. The rest of the regimen calls for J&J’s bedaquiline — perhaps better known as Sirturo — the off-patent antibiotic moxifloxacin, and pyrazinamide, a generic med often found in TB combos.
Dubbed SimpliciTB, the trial will be conducted among 450 patients across Africa, Asia, Europe and Latin America, with the first patient already enrolled in Tbilisi, Georgia.
There are two goals. First, researchers want to find out whether the BPaMZ regimen can indeed treat drug-sensitive TB more quickly and effectively — something they have observed in a smaller, shorter Phase II trial — by comparing four months of that to six months of the standard isoniazid, rifampicin, pyrazinamide and ethambutol (HRZE) combo.
The second assessment is on the new regimen’s potential in multi-drug resistant tuberculosis — current treatments tend to be expensive, lengthy and involve injectable drugs.
“As resistance to current TB treatments continues to grow, we need to introduce all-oral drug regimens that can treat every person with TB in six months or less, regardless of their resistance profile,” said Mel Spigelman, president and CEO of TB Alliance. “If proven successful in SimpliciTB, the BPaMZ regimen would represent a major step toward this goal.”
Tuberculosis is among the fatal ailments that continue to afflict low-income countries but receive little R&D action. Non-profits have largely been picking up the charge; the Gates Foundation has made it one of its priorities by backing infectious disease startup Vir and, recently, setting up a biotech-like institute to test a tuberculosis prevention program itself.
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