South Africans will feature among 300 participants in five-country phase 2 clinical trials for a new drug-resistant, drug-sensitive TB treatment – launched by the global NGO TB Alliance – to evaluate a combination of experimental compound TBAJ-876 with pretomanid and linezolid.
They are components of TB Alliance’s BPaL regimen, reports News24, which has the potential to shorten and improve treatment for both drug-sensitive and drug-resistant TB.
Results from pre-clinical and phase 1 studies showed that the new compound, when compared with bedaquiline (a TB medicine in the same drug class), eliminated TB bacteria faster and had a potentially safer profile.
South Africa has one of the highest TB burdens in the world, killing an estimated 56 000 people in 2021, according to the World Health Organisation (WHO), and Dr Francesca Conradie, principal investigator for the clinical trial in this country, said there was a need to continually innovate to get ahead of the TB pandemic here.
“Recent innovations in drug-resistant TB therapy have been enormously important, but we need to continue to develop shorter, simpler, and more people-friendly cures, including in drug-sensitive TB, where there hasn't been a new drug approved in more than fifty years,” she said.
Dr Mel Spigelman, the president and CEO of TB Alliance, said a universal TB medicine needed to be highly effective while causing few adverse effects.
“Initial phase 1 trial results show that TBAJ-876 could move the needle in this direction. If we can develop a regimen composed of novel compounds with minimal pre-existing resistance that is both highly potent and safe, it could blur the distinction between drug-sensitive and drug-resistant tuberculosis, allowing for the treatment of virtually all patients with active TB with the same regimen,” he said.
Spigelman said that although tuberculosis was preventable and mostly curable with early detection and proper treatment, drug-resistant TB was much more complex and more expensive to treat.
“Treatment can be very long and involves a combination of drugs, some of which have substantial side effects. The introduction of bedaquiline to treat the disease in the past decade has led to the development of much shorter regimens with improved outcomes for those with drug-resistant TB. But resistance to the drug, which is part of all standard drug-resistant tuberculosis regimens globally, has emerged. So TBAJ-876 might play an essential role in future.”
See more from MedicalBrief archives:
TB diagnoses reached record high last year – WHO report
FDA recommends TB Alliance’s MDR-TB treatment regimen
What next for TB treatment after disappointing results for shortened regime?
SA in multi-million dollar trial for new TB vaccine
Drug combo for six months successful in treating drug-resistant TB