TB Alliance to Present Phase 2 Results for Sorfequiline, Next-Generation TB Drug Candidate
核心洞察
TB Alliance will present clinical trial results for sorfequiline (搜索) (TBAJ-876), a next-generation diarylquinoline antibiotic, at the World Conference on Lung Health in Copenhagen on November 19, 2025.
The NC-009 phase 2 trial evaluated sorfequiline (搜索) combined with pretomanid and linezolid across 22 sites in five countries, comparing efficacy and safety against standard TB treatments.
Earlier trial results demonstrated that sorfequiline (搜索) has a better safety profile than bedaquiline and potential to treat bedaquiline-resistant tuberculosis (搜索) strains.
TB Alliance will present pivotal clinical trial results for sorfequiline (搜索) (TBAJ-876), a novel next-generation diarylquinoline antibiotic, at the World Conference on Lung Health in Copenhagen on November 19, 2025. The presentation will reveal whether this promising drug candidate has the potential to shorten tuberculosis (搜索) treatment duration when replacing bedaquiline in established treatment regimens.
Phase 2 Trial Design and Scope
The not-for-profit organization conducted the NC-009 trial, a Pan-phase 2 randomized controlled study, across 22 sites in South Africa, the Philippines, Georgia, the United Republic of Tanzania, and Uganda. The trial evaluated different doses of sorfequiline (搜索) in combination with pretomanid and linezolid in people with drug-sensitive tuberculosis (搜索).
The study compared the efficacy and safety profile of sorfequiline (搜索)-based combinations against two established regimens: the BPaL regimen (bedaquiline, pretomanid, and linezolid) and the HRZE regimen (isoniazid, rifampin, pyrazinamide, and ethambutol), which serves as the standard first-line treatment for drug-sensitive tuberculosis (搜索).
Addressing Critical Treatment Challenges
Tuberculosis (搜索) presents significant treatment challenges, requiring patients to take combination medicines for at least four to six months. Even after symptoms disappear, continued medication is necessary to fully eradicate all traces of the disease. The global tuberculosis pandemic is largely fueled by antiquated and inadequate drug options, creating an urgent need for novel regimens.
Current treatment limitations are particularly severe for drug-resistant cases. Previously, less than two-thirds of drug-resistant tuberculosis (搜索) patients worldwide achieved successful treatment outcomes. Available options were limited, expensive, toxic, and lengthy, requiring patients to take more than 20 pills daily for 9-20 months.
Next-Generation Diarylquinoline Development
Sorfequiline (搜索) and bedaquiline both belong to the diarylquinoline class of antibiotics, which target a key enzyme in tuberculosis (搜索) bacteria involved in energy production. Bedaquiline, approved in 2012 for drug-resistant tuberculosis (搜索) treatment, marked the first new antibiotic approval in decades. However, tuberculosis strains resistant to bedaquiline are now emerging, highlighting the need for next-generation alternatives.
Earlier trial results demonstrated that sorfequiline (搜索) offers a better safety profile than bedaquiline while maintaining potential to treat many bedaquiline-resistant strains. This represents a significant advancement in addressing evolving drug resistance patterns.
Regulatory Precedent and Development Pipeline
The BPaL regimen, first clinically studied by TB Alliance, achieved a significant milestone when pretomanid received its first regulatory approval in August 2019 for use against highly drug-resistant tuberculosis (搜索) strains. This approval established a precedent for innovative combination therapies in tuberculosis (搜索) treatment.
Sorfequiline (搜索) represents a product of TB Alliance's comprehensive drug discovery work, with the organization managing the compound's development from early discovery through late-stage clinical trials, following the same pathway previously used for pretomanid. This end-to-end development approach demonstrates the organization's commitment to bringing novel tuberculosis (搜索) treatments to patients worldwide.