TenNor Therapeutics has reported positive top-line data from a Phase IIa trial assessing its drug candidate, rifaquizinone (TNP-2092), in patients with periprosthetic joint infection (PJI).
Conducted in China, the study focused on patients with early, acute or chronic PJI, with TNP-2092 delivered via intra-articular injection alongside background systemic antibiotic therapy.
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It is a proof-of-concept (POC) trial and enrolled ten patients. Of these, seven were included in the efficacy analysis based on confirmation of Gram-positive infection by culture or next-generation sequencing.
Two patients were excluded due to culture-negative results, and one patient had not yet reached efficacy assessment at the time of analysis.
Among five patients with early or acute PJI who completed six months of follow-up, all reported treatment success. Four of these reached the 12-month follow-up, again reporting 100% treatment success.
In the chronic PJI group, two patients received TNP-2092 and completed six months of follow-up, with one achieving treatment success. 12-month data for this subgroup were not available as of the analysis date.
Safety analysis included nine patients, with no TNP-2092-related treatment-emergent adverse events or serious adverse events identified.
The tenth patient, still under observation at the analysis cut-off, had also reported no TNP-2092-related adverse events.
Following these results, TenNor Therapeutics has begun a multi-centre Phase IIb trial to further evaluate TNP-2092, after approval from China’s National Medical Products Administration (NMPA).
The company describes TNP-2092 as a first-in-class, triple-targeting drug designed for implant-associated biofilm infections.
Xinjiang Medical University First Affiliated Hospital Orthopedics Center chief physician Professor Li Cao is the principal investigator of the POC trial.
Li Cao said: “PJI is a devastating condition, and currently, patients have very limited treatment options. TNP-2092 represents a paradigm shift in PJI therapy.
“The combination of TNP-2092, a novel biofilm-eradicating agent with intra-articular delivery, offers the potential to cure PJI without subjecting patients to the painful, prolonged, and costly surgical pathway.”
TNP-2092 has previously received qualified infectious disease product, fast track, and orphan drug designations from the US Food and Drug Administration (FDA) for PJI.
In November 2024, TenNor Therapeutics reported that a Phase III trial of its antibiotic candidate, rifasutenizol, has met all primary endpoints, beating out the current standard of care (SoC).
