TENNOR THERAP-B(06872): First patient enrolled in the multicenter Phase IIb clinical trial of rifaquizone (TNP-2092) administered via intra-articular injection for the treatment of prosthetic joint infection

TENNOR THERAP-B (06872) announced that the first patient has been enrolled in the multicenter Phase IIb clinical trial of its investigational drug candidate rifaquizone (TNP-2092) administered via intra-articular injection for the treatment of prosthetic joint infection (PJI). The trial is designed to further evaluate the efficacy, safety, and pharmacokinetic profile of rifaquizone (TNP-2092) in treating PJI without debridement or revision surgery, marking a critical stage in the clinical development of this potentially disruptive novel drug product. The Phase IIb clinical trial is a randomized, controlled, open-label, multicenter clinical study (Trial ID: NCT07858916; China Drug Clinical Trial Registration No.: CTR20263531), with a planned enrollment of 40 adult subjects. The trial will evaluate the efficacy, safety, and pharmacokinetic profile of intra-articular injection of rifaquizone in patients with early PJI after knee arthroplasty (within 3 months post-surgery) or acute hematogenous PJI (within 4 weeks of infection symptoms), on the basis of systemic background antibiotic therapy and avoidance of debridement or replacement surgery; it will also assess the efficacy of intra-articular injection of rifaquizone in chronic PJI patients requiring long-term antibiotic suppressive therapy. The primary study endpoint is efficacy at 6 months after initiation of study treatment.