May 5, 2025 – TenNor’s new drug for H. pylori infection, Rifasutenizol (TNP-2198) made its debut at Digestive Disease Week (DDW) 2025 in San Diego, USA. A conference abstract titled “The Efficacy and Safety of Rifasutenizole (TNP-2198) Based Triple Regimen as First-Line Therapy For Helicobacter pylori Infection: A Multicenter, Double-Blind, Randomized, Controlled, Phase 3 Trial”, submitted by Professor Zhou Liya and Professor Song Zhiqiang from Peking University Third Hospital, along with Professor Wang Weihong from Peking University First Hospital, was selected for presentation at the Distinguished Abstract Plenary Session.

Rifasutenizol is the first new drug specifically developed for Helicobacter pylori (H. pylori) infection in 40 years since its discovery. It possesses a unique multi-targeting synergistic mechanism of action, exerting antibacterial activity by inhibiting bacterial RNA polymerase and generating reactive species by nitroreductase. Rifasutenizol demonstrates potent antibacterial activity against Hp clinical isolates (including drug-resistant strains) and exhibits an extremely low frequency for spontaneous resistance mutation (<10⁻¹¹). In early-stage clinical development, a rifasutenizol-based triple therapy (RTT) showed excellent efficacy for H. pylori eradication, and identified as a promising first-line treatment for Hp infection.

Professor Song Zhiqiang, on behalf of all investigators, presented the key findings from a randomized, double-blind, bismuth-quadruple therapy (BCTT) controlled phase III trial (EVEREST-HP). conducted in 40 centers in China. The trial screened 1,267 patients, with 700 successfully randomized. The H. pylori culture success rate was 83.1%. Antimicrobial susceptibility testing revealed resistance rates of 40.8% for clarithromycin, 68.2% for metronidazole, 35.1% for levofloxacin, and 8.1% for amoxicillin. Alarmingly, 85.1% of these clinical isolates were resistant to at least one guideline-recommended antibiotic, and 46.3% were multidrug resistance (MDR), underscoring the urgent need for new antimicrobial agent for Hp infection. All clinical isolates remained susceptible to rifasutenizol.

In the modified intention-to-treat (mITT) analysis, the eradication rates were 92.0% (RTT) vs. 87.9% (BCTT), difference of 4.2% (95% CI: -0.3% to 8.3%, P for non-inferiority <0.0001), confirming RTT’s non-inferiority to BCTT. The advantage of RTT was more pronounced in antibiotic-resistant subgroup analyses, particularly in MDR populations, where eradication rates were 89.9% (RTT) vs. 81.2% (BCTT), difference of 8.7% (95% CI: 0.1% to 17.1%, P for superiority = 0.023). The incidence of treatment-emergent adverse events (TEAEs) was lower in the RTT group (37.3% vs. 53.2%), with most being mild to moderate and no serious adverse events (SAEs) reported.

H. pylori infection, affecting around half of the world population, causes chronic gastritis, which can further progress to severe gastroduodenal pathologies, including peptic ulcer, gastric cancer (GC), and mucosa-associated lymphoid tissue (MALT) lymphoma. H. pylori infected individuals have a 2 to 6-fold higher risk of GC. The causal relationships of H. pylori infection to GC have been demonstrated by studies conducted in the first-degree relatives or in high-risk regions of GC. The incidence rates of GC decreased by 14%~72% during 9~26 years of follow up after H. pylori eradication. H. pylori infection appeared to be a more important risk factor for GC than the germline pathogenic variants in cancer-predisposing genes. In China, H. pylori was associated with the highest disease burden among 85 leading pathogens, causing 7.21 million disability-adjusted life-years (DALYs) in 2019. A study estimated that up to 35.5% of the 10 million new GC cases projected to occur between 2021 and 2035 in China could be avoided by implementing H. pylori screening-eradication strategies.

Digestive Disease Week (DDW) is the world’s premier GI conference, co-hosted by the American Association for the Study of Liver Diseases (AASLD), American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE), and Society for Surgery of the Alimentary Tract (SSAT).

About TenNor Therapeutics

TenNor Therapeutics is a clinical-stage company specialized in the discovery and development of differentiated new drug products in diseases associated with bacterial infection and metabolism. TenNor possesses a unique multi-targeting drug conjugate technology platform and a strong new drug development pipeline with global IP protection. Several products are currently in late stage of clinical development or marketing application stage, targeting H. pylori infection, implanted medical device infections, hepatic encephalopathy and irritable bowel syndrome with diarrhea. The company is committed to address the unmet needs in the disease area and provide safe and effective therapies for patients in China and around the world.

For more information, please visit: www.tennorx.com