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Sorfequiline Outperforms Standard TB Regimens in Phase 2 Trial

Public-health experts urge a cautious rollout given diagnostic capacity constraints.

Overview

  • TB Alliance reported that a sorfequiline, pretomanid and linezolid regimen (SPaL) showed greater bactericidal activity than bedaquiline-containing therapy and the standard HRZE regimen with a comparable safety profile.
  • The NC-009 pan-Phase 2 trial enrolled 309 participants across 22 sites in South Africa, the Philippines, Georgia, Tanzania and Uganda.
  • By the week-8 primary endpoint, 59% of participants on 100 mg sorfequiline achieved stable sputum conversion versus 45% on BPaL and 45% on standard care, and eligible participants in the high-dose arm could stop therapy by week 15.
  • TB Alliance plans to launch a Phase 3 trial in 2026 and is exploring a long-acting injectable formulation that could potentially compress treatment to about one month.
  • Developers propose the regimen could be started before resistance status is known to simplify care, while conference speakers cautioned about risks of overexposure and reduced incentives to build testing capacity.