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The drug could shorten treatment by several months without compromising safety, researchers say, as presented at the Union World Conference on Lung Health in Copenhagen on Nov. 19.
The NC-009 pan-phase II clinical trial, conducted at 22 sites in South Africa, the Philippines, Georgia, Tanzania and Uganda, included at least 309 patients with drug-sensitive tuberculosis. Participants were administered a “SPAL” regimen consisting of sorfequiline (TBAJ-876), pretomanide, and linezolid.
According to the trial results, sorfequiline combination treatment outperformed standard drug-sensitive TB combination treatment consisting of isoniazid, rifampin, pyrazinamide and ethambutol.
By week eight, 59% of the sorfequiline group reached stable sputum conversion (SSC), an important early marker for treatment effectiveness, at the maximum tested dose (100 mg).
In contrast, only 45% of patients in the BPaL arm (bedaquiline, pretomanide, and linezolid) and the standard-care arm (isoniazid, rifampin, pyrazinamide, and ethambutol) achieved that goal.
Surprisingly, if patients had a negative sputum test at week 8, 64% of those in the highest dose sorfequiline group could discontinue treatment by week 15.
According to TB Alliance trial investigator Maria Beaumont, MD, the results are “a very good indication of the fact that the treatment is more efficacious” because it is reducing mycobacterium burden faster than other treatments.
“This is an indication of efficacy or robustness, but also the potential to shorten treatment,” Baymount said.
“The treatment was excellent. It was shorter and simpler than I expected,” said Thuto Pulane, a participant in the NC-009 clinical trial.
SPaL will be an all-oral treatment for tuberculosis, and sorfequiline is designed as a pill. The TB Alliance intends to explore administering sorfequiline-based regimens as a long-acting injectable (LAI), a formulation that could help reduce treatment duration to at least one month, in addition to the future SPAL phase 3 trial.
Apart from its high activity, sorfequiline had a similar safety profile to conventional treatments.
Additionally, early studies indicate that it is well tolerated by patients and may have less cardiovascular toxicity than the current next-generation TB drug, bedaquiline. It is easier to give sorafequiline as an oral medicine in situations where frequent or daily clinic visits are a burden.
According to experts, this breakthrough has the potential to revolutionize the game. A universal sorafequiline-based regimen can be used for patients immediately after diagnosis, even before thorough drug-resistance testing. This will be revolutionary for areas with limited laboratory space and long test result delays.
However, caution remains. According to Dr. Kavindran Velen, chief scientific officer of the International Union Against Tuberculosis and Lung Disease, a “one-size-fits-all” drug approach could deter investment in clinical facilities.
He expressed concern that expanding its use to all TB patients would have negative impacts, such as discouraging health systems from investing in broader advances such as laboratories and testing.
According to data reported by WHO, 1.23 million people died from tuberculosis in 2024, and an estimated 10.7 million individuals became infected.