NC-010

NC-010 is a Phase 2b clinical trial designed to build upon the promising results of the NC-009 study and support the advancement of sorfequiline (TBAJ-876) into Phase 3 development. While NC-009 demonstrated that sorfequiline-containing regimens had greater bactericidal activity than both BPaL and standard first-line therapy, NC-010 is intended to answer key remaining questions about dose selection, longer-term safety, and optimal regimen design before initiation of the pivotal NC-011 Phase 3 trial.
The study evaluates the SPaL regimen (sorfequiline, pretomanid, and linezolid) in patients with drug-sensitive tuberculosis at clinical sites in South Africa and Tanzania.

Participants are randomized to receive either a 17-week regimen containing 100 mg sorfequiline or a regimen utilizing a higher sorfequiline dose designed to achieve approximately 40% greater drug exposure than was evaluated in NC-009. The trial is set to use the same eligibility criteria and monitoring framework as NC-009, allowing investigators to directly compare findings across studies.

A primary objective of NC-010 is to determine whether higher sorfequiline exposure can further improve treatment efficacy while maintaining the favorable safety profile observed in earlier studies. The trial will also provide important safety data from longer treatment durations, helping researchers better understand the effects of extended sorfequiline exposure and supporting dose selection for future registration studies.

The importance of NC-010 extends beyond the study itself. Historically, multiple attempts to shorten TB treatment to four months have failed. By generating additional safety, pharmacokinetic, and efficacy data on sorfequiline, NC-010 is designed to reduce the development risk associated with NC-011, the Phase 3 study planned to evaluate a four-month SPaL/M regimen for drug-resistant TB. The findings will help ensure that the dose selected for Phase 3 maximizes the likelihood of achieving both treatment-shortening and regulatory approval objectives.

NC-010 therefore serves as a critical bridge between proof-of-concept and registration. The study is expected to provide the evidence needed to optimize sorfequiline dosing, strengthen confidence in the safety profile of the regimen, and position TB Alliance to pursue approval of both a next-generation diarylquinoline and a new four-month treatment regimen for drug-resistant TB.