PDP FG 2024

 

 

Toward a Universal Regimen:
The Promise of TBAJ-876 and the NC-009 Clinical Trial

TB Alliance’s ultimate vision for TB therapy is an ultra-short, highly effective, and safe regimen capable of treating all forms of tuberculosis (TB). A regimen comprised fully of novel agents that meets the safety and efficacy of the current standard of care for “drug-sensitive TB” could be used to treat any form of active TB. Such an advance could essentially erase the concept of drug-resistant TB, and with it the world’s leading cause of AMR-related deaths, simplifying therapy for people with TB, care providers, and health systems alike. TB Alliance’s new drug candidate, TBAJ-876 and the NC-009 trial represent the next major step toward realizing this vision.

In recent years, TB Alliance has developed, launched, and worked to drive access to the BPaL (bedaquiline + pretomanid + linezolid) regimen, which is widely approved and recommended for treating most forms of drug-resistant TB, but not drug-sensitive TB. The NC-009 trial builds on the success of BPaL; it investigates whether replacing the “B” in BPaL with TBAJ-876 can yield the first universal regimen. Based on previous non-clinical studies, the combination of TBAJ-876 + pretomanid + linezolid shows potential to further shorten treatment for both drug-sensitive and drug-resistant TB, combat emerging resistance to bedaquiline, and offer a safety profile similar to that of current drug-sensitive TB treatment. In other words, it has potential to be appropriate for treating all active TB.

NC-009 was initiated in late 2023. It has already surpassed the halfway point of its enrollment target of 300 participants across 21 sites in five countries. Its innovative design combines the elements of Phase 2A, B, and C trials in one Pan-Phase 2 trial, significantly accelerating the development pathway for this promising new regimen.

 


NC-009 and TBAJ-876 Info Center

Poster (presented at South Africa TB Conference)

Potential Impact on Anti-mycobacterial Study Design and Tuberculosis Treatment Landscape Innovative Design of the TBAJ876 Phase 2 NC-009 Study

Publications

News Releases

 

Without Community, Research is not Possible

The NC-009 trial is conducted in concert with a robust community engagement program, which educates and empowers affected communities proximate to trial sites to meaningfully participate in and help shape the local research processes. As the first organization to establish community advisory groups in TB research, TB Alliance sees research and community work as complementary and interrelated, advancing the equity, quality, and impact of its work.

TB Alliance and Affected Communities

Poster (presented at South Africa TB Conference)

Engagement of Males with Pulmonary Drug-Resistant Tuberculosis for Participation in Pretomanid Regimen (BPaMZ) Testicular Safety Study

More Stories of TB Survivors and Affected Communities

Key Info on TB in South Africa

 

Delivering Impact: Driving the Fastest Ever Roll-out of New DR-TB Treatments

TB Alliance’s goals are not fulfilled until the products it develops reaches those in need. Since BPaL’s initial approval, it has been approved by more than 25 regulatory authorities and recommended by the Word Health Organization to treat almost all forms of drug-resistant TB. TB Alliance’s market access efforts, including our LIFT-TB initiative have powered what has come to be fastest uptake of new drug-resistant TB therapy in history. Today, BPaL more than 40,000 courses of BPaL have been procured across more than 70 countries. This is a fantastic start, but more work is required. TB Alliance continues to advance a wide array of market access initiatives to help accelerate and smooth the global transition from older drug-resistant TB treatments to BPaL-based therapies.

Signature TB Alliance Access Initiatives

The LIFT-TB initiative seeks to save the lives and livelihoods of people with TB their families, and their communities by broadening and accelerating the adoption and scale up of novel drug-resistant TB (DR-TB) treatment regimens and reducing the burden on health systems. Initially centralizing operations in South East and Central Asia, LIFT-TB countries conducted a series of operational research studies that has helped guide the way for rapid and wide implementation of BPaL.

Headquartered in Manila and launched in March of 2024, the PeerLINC Knowledge Hub leverages a peer-to-peer model of information and experience sharing to accelerate the programmatic implementation of innovative TB treatments globally. Currently it focuses on rapid BPaL-adopting countries providing practical training and technical support to support other countries interested in implementing BPaL. PeerLINC operates in partnership with the Tropical Diseases Foundation Inc (TDF), and the Department of Health, Philippines.

SLASH-TB is an interactive model designed for countries to use to estimate cost savings for health systems, people with TB, families, and/or care givers when using the BPaL/M regimens, as compared with standard drug-resistant TB treatments. The model can be used at the country, state, or even hospital level. This tool can be used to build evidence to support policy change, funding for new regimen implementation, as well as for internal budgeting or fundraising purposes.