Prime Highlight
- Sorfequiline (TBAJ-876) in the SPaL regimen demonstrated greater activity against TB than bedaquiline, marking a major advancement in global TB treatment.
- The 100 mg SPaL regimen outperformed standard HRZE therapywith a comparable safety profile, raising hopes for shorter TB treatment durations.
Key Facts
- The NC-009 Phase 2 trial was conducted by TB Alliance across 22 sites in South Africa, the Philippines, Georgia, Tanzania, and Uganda.
- A Phase 3 trial is planned for 2026in partnership with high-burden countries, including India, China, South Africa, Indonesia, and Brazil.
Background
New clinical trial results presented by TB Alliance at the Union World Conference on Lung Health indicate that the novel antibiotic candidate sorfequiline (TBAJ-876) may significantly advance global tuberculosis (TB) treatment. The pan-Phase 2 NC-009 trial shows that sorfequiline, when used in the SPaL regimen with pretomanid and linezolid, delivers greater activity against TB than bedaquiline, a key drug currently used worldwide.
The study also found that the 100 mg SPaL regimen worked better than the standard HRZE treatment, the current first-line therapy for drug-sensitive TB. Researchers noted that SPaL matched the safety profile of existing treatments, raising hopes that it could shorten therapy duration for millions of patients.
TB Alliance conducted the NC-009 trial across 22 sites in South Africa, the Philippines, Georgia, Tanzania and Uganda. Dr. Mel Spigelman, President and CEO of TB Alliance, said the results bring the world closer to achieving ultra-short treatment for both drug-sensitive and drug-resistant TB. He pointed out that sorfequiline works against strains that no longer respond to bedaquiline, which is becoming a global concern.
TB Alliance developed Sorfequiline, a next-generation diarylquinoline, from early discovery to late-stage trials. Early results show it may be safer while still fighting resistant bacteria effectively.
The organisation is now preparing for a Phase 3 trial in 2026, in partnership with high-burden countries including India, China, South Africa, Indonesia, and Brazil. Researchers will test the SPaL regimen as an all-oral therapy and also study sorfequiline as a long-acting injectable that could cut treatment to just one month.
Participants in the trial shared positive experiences, expressing hope that future TB treatment will be shorter, safer, and easier. TB Alliance says this progress brings them closer to their long-term goal of ending TB worldwide.
