TenNor Reports Positive Rifasutenizol Phase III Trial Results for H. pylori

SUZHOU, China, Nov 18, 2024 -- TenNor Therapeutics, a company focused on developing innovative treatments for infectious diseases, announced the successful conclusion of a phase III clinical trial for rifasutenizol (TNP-2198). This trial evaluated the drug's effectiveness in treating Helicobacter pylori (H. pylori) infections. The study achieved its main objectives, demonstrating several benefits of the rifasutenizol regimen compared to the standard bismuth-containing quadruple therapy (BQT).

The phase III trial was a multicenter, randomized, double-blind, and controlled study, examining the efficacy and safety of TNP-2198 combined with amoxicillin and rabeprazole in patients who had not previously been treated for H. pylori infection. Conducted in 40 hospitals across China, the trial involved 700 patients confirmed to have H. pylori through a positive carbon-13 urea breath test (C-13 UBT) and histological examination. Participants were divided equally into two groups: one received a regimen of rifasutenizol, amoxicillin, and rabeprazole, while the other received BQT. The treatment lasted for 14 days, and the primary effectiveness measure was the result of a C-13 UBT test conducted 4 to 6 weeks after the treatment ended.

The trial noted high patient compliance, with a low dropout rate of 3%. H. pylori cultures were successfully obtained from 87% of patients. There were no significant demographic or baseline differences in antibiotic resistance characteristics between the two groups that could influence the study results. The resistance rates to clarithromycin, metronidazole, levofloxacin, and amoxicillin among H. pylori isolates were 41%, 68%, 35%, and 8% respectively, reflecting the serious issue of antibiotic resistance in China. Notably, all clinical isolates in the study were susceptible to rifasutenizol.

The rifasutenizol regimen achieved an eradication rate of over 90% in the modified intention-to-treat (mITT) population, which was higher than the BQT control (92.0% vs. 87.9%, with significant results in non-inferiority and superiority tests). In the per-protocol (PP) population, the rifasutenizol regimen also showed a higher eradication rate than BQT (93.7% vs. 90.3%, with significant results in non-inferiority tests). Moreover, in patients with H. pylori resistant to any of the current antibiotics, the rifasutenizol regimen was again more effective than BQT (90.9% vs. 87.2%, with significant results in non-inferiority tests).

In terms of safety and tolerability, the rifasutenizol regimen had a better profile compared to BQT. The incidences of treatment-emergent adverse events (TEAEs), drug-related TEAEs, and severe TEAEs were lower in the rifasutenizol group. Most TEAEs were mild (Grade 1), and there were no serious adverse events related to the investigational drug.

Rifasutenizol represents a novel multi-targeting drug candidate with a synergistic action mechanism against anaerobic and microaerophile bacteria. It has the potential to be the first new drug specifically developed for H. pylori infection in over three decades. This drug could significantly contribute to large-scale test-and-treat strategies aimed at preventing gastric cancers, especially in high-risk populations. The rifasutenizol regimen does not necessitate drug sensitivity tests and integrates seamlessly with UBT testing. TenNor has completed seven phase I-III clinical trials in China and received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA).

TenNor Therapeutics specializes in the discovery and development of new drug products for bacterial infections and metabolic diseases. The company uses a unique multi-targeting drug conjugate technology and has a robust pipeline of new drugs with global intellectual property protection. Currently, TenNor is developing treatments for H. pylori infection, medical device infections, hepatic encephalopathy, and irritable bowel syndrome with diarrhea. Committed to addressing unmet needs, the company aims to provide safe and effective therapies for patients globally.