TenNor Therapeutics Reports Positive Phase IIa POC Data for Rifaquizinone (TNP-2092), the First Non-Surgical Therapy Candidate for Periprosthetic Joint Infection

— Phase IIb multicenter trial initiated, bringing this potential life-changing therapy closer to patients —

SUZHOU, China, Sept. 10, 2026 /PRNewswire/ -- TenNor Therapeutics, a near-commercial-stage biotechnology company, today announced positive topline results from a Phase IIa proof-of-concept (POC) trial of rifaquizinone (TNP-2092), a first-in-class, triple-targeting drug candidate administered via intra-articular (IA) injection for the treatment of periprosthetic joint infection (PJI). The data suggest that TNP-2092 has the potential to cure PJI without surgical intervention—a paradigm shift that could fundamentally transform patient outcomes. Based on the findings, the company has initiated a multicenter Phase IIb trial to accelerate clinical development.

The Unmet Need in PJI

PJI is a devastating complication that can turn a successful joint arthroplasty into a medical and personal crisis. Approximately 45,000 new cases occur annually in the U.S. and 22,000 in China, yet treatment remains exceptionally challenging due to bacterial biofilm formation, which largely undermines the efficacy of conventional antibiotics. Surgical intervention is considered essential, as antibiotic‑only regimens carry unacceptably high failure rates.

Patients currently face suboptimal surgical pathways: debridement, antibiotics, and implant retention (DAIR) for early postoperative (early) or acute hematogenous (acute) PJIs—with reported failure rates exceeding 30%—or a two-stage revision for chronic PJIs that requires multiple surgeries, extended hospitalization, and months of functional impairment, while still failing in over 10% of cases. The economic burden is staggering, with per-patient costs in the U.S. frequently surpassing $390,000. Compounding the challenge, the rising volume of joint replacements is driving a steep increase in PJI incidence; by 2035, an estimated 425,800 new PJI cases are expected globally—including 86,500 in China.

Phase IIa Proof-of-Concept Trial Results

This Phase IIa POC clinical trial, conducted in China, evaluated IA administration of TNP-2092 plus systemic antibiotic background therapy—without debridement or joint replacement—in patients with early or acute PJIs. Patients with chronic PJI requiring long-term antibiotic suppression therapy were also included in the study.

As of July 1, 2026, data lock point (DLP) for interim analysis: 10 patients were enrolled. Seven patients with culture- or next-generation sequencing (NGS)-confirmed Gram-positive infections were included in the efficacy analysis. Two patients were excluded from the efficacy analysis due to culture-negative results. One patient had been newly enrolled as of the DLP, with efficacy data not yet available.

Efficacy: Among the five patients with early or acute PJI who received TNP-2092 IA, all had completed the 6-month follow-up, with 100% (5/5) treatment success reported. Among the four patients who had completed the 12-month follow-up, 100% (4/4) treatment success was reported. Of the two patients with chronic PJI who received TNP-2092 IA and had completed the 6-month follow-up, 50% (1/2) treatment success was reported; 12-month follow-up data were pending as of the DLP.

Safety: Nine patients were included in the safety analysis, with no TNP-2092-related treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) reported. The remaining patient, still undergoing follow-up, also reported no TNP-2092-related TEAEs or SAEs as of the DLP.

These topline results demonstrate promising efficacy and a favorable safety profile for TNP-2092 IA, supporting the accelerated clinical development of this novel non-surgical approach to PJI treatment.

Multicenter Phase IIb Trial Initiated

A multicenter Phase IIb clinical trial to further evaluate TNP-2092 IA has received approval from China's National Medical Products Administration (NMPA), and the trial has recently been initiated.

Expert Commentary

Professor Li Cao, Chief Physician at the Orthopedics Center of the First Affiliated Hospital of Xinjiang Medical University, and the Principal Investigator for the POC trial:

"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. I am extremely excited to see patients in this trial achieve cure—sparing them from the grueling surgical journey they would otherwise face."

Professor Javad Parvizi, MD, FRCS, Professor of Orthopedic Surgery, Acibadem University, Istanbul, past president of the American Association of Hip and Knee Surgeons, and Co-Chair, International Consensus Meeting (ICM) on PJI:

"Orthopedic surgery has seen remarkable breakthroughs that have changed countless lives—yet the management of PJI has remained stubbornly stagnant. The field is in urgent need of truly transformative innovation. I am excited by the proof-of-concept data for TNP-2092, which I believe has the potential to dramatically improve outcomes and quality of life for PJI patients."

About Rifaquizinone (TNP-2092)

TNP-2092 is a first-in-class, triple-targeting drug candidate specifically engineered to address the critical unmet need in implant-associated biofilm infections. Its distinct mechanism of action synergistically inhibits bacterial RNA polymerase, DNA gyrase, and topoisomerase IV—a triple-targeting approach that not only confers potent activity against resistant pathogens, including Methicillin-resistant Staphylococcus aureus (MRSA) and Quinolone-resistant S. aureus (QRSA), but also drives an exceptionally low resistance frequency of <10⁻¹².

TNP-2092 has demonstrated potent biofilm bactericidal activity in both in vitro and in vivo models, outperforming current standard-of-care antibiotics. The company has successfully completed six Phase I and Phase II clinical trials in the United States and China, with TNP-2092 showing a favorable safety profile and excellent efficacy against acute bacterial skin and skin structure infections (ABSSSI).

The U.S. Food and Drug Administration has granted TNP-2092 Qualified Infectious Disease Product (QIDP), Fast Track, and Orphan Drug designations for the treatment of PJI. Additionally, TNP-2092 received the Excellence Award at China's National Disruptive Technology Innovation Competition.

About TenNor Therapeutics

TenNor Therapeutics is a near-commercial-stage biotechnology company dedicated to the discovery, development, and commercialization of differentiated therapies to address unmet medical needs in disease areas associated with bacterial infections and bacterial metabolism. Empowered by its proprietary multi-targeting conjugate molecule technology, TenNor Therapeutics aims to deliver the best therapeutic solutions to overcome the limitations of conventional treatments and improve patient outcomes.

As of June 30, 2026, TenNor Therapeutics had built a pipeline of eight innovative programs, including two Core Products: Rifasutenizol (TNP-2198) – a new molecular entity (NME) drug candidate used as part of a triple therapy for the treatment of Helicobacter pylori (H. pylori) infection. Rifaquizinone (TNP-2092) – a triple-targeting antibacterial drug candidate for the treatment of implant-associated bacterial infections, including periprosthetic joint infection (PJI), left ventricular assist device infection (LVADI), and catheter-related bloodstream infection (CRBSI).

Forward-Looking Statements

This press release contains forward-looking statements regarding TenNor Therapeutics' product development, clinical trial plans, and regulatory pathways. Actual results may differ materially due to various risks and uncertainties. TenNor undertakes no obligation to update these statements except as required by law.

SOURCE TenNor Therapeutics (Suzhou) Limited