According to the Zhitong Finance App, Danno Pharmaceutical-B (06872) announced that the multi-center phase IIb clinical trial of rifuquinone (TNP-2092), a new drug candidate currently being developed by the company to treat artificial joint infections (PJI) through intra-articular injection, has completed the first patient enrollment. The trial aims to further evaluate the efficacy, safety, and pharmacokinetic characteristics of rifaquinone (TNP-2092) in treating PJI without debridement or revision surgery, marking a critical stage in the clinical development of this potentially disruptive new drug product.
The phase IIb clinical trial is a randomized, controlled, open-label multicenter clinical study (trial number: NCT07858916; Chinese drug clinical trial registration number: CTR20263531). It is planned to enroll 40 adult subjects. The trial will evaluate the efficacy, safety, and pharmacokinetic characteristics of patients with intra-articular administration of rifuquinone in the early stages (within 3 months after surgery) or acute hematogenous (within 4 weeks of symptoms of infection) after knee replacement surgery, on the basis of systematic antimicrobial background treatment and avoidance of debridement or replacement surgery; at the same time, it will evaluate the efficacy of patients with chronic PJI requiring long-term antibiotic suppression treatment receiving intra-articular administration of rifoquinone. The main end point of the study was to study the effectiveness 6 months after starting treatment.