Suzhou/China, December 12, 2023 – TenNor Therapeutics reports positive results from interim analysis of rifasutenizol (TNP-2198) phase III clinical trial for the treatment of Helicobacter pylori (H. pylori) infection.

The ongoing Phase III clinical trial is a multi-center, randomized, double-blind study to compare the safety and efficacy of a rifasutenizol triple regimen (rifasutenizol 400 mg, amoxicillin 1000 mg and rabeprazole 20 mg, twice daily for 14 days) and a standard bismuth-containing quadruple therapy (bismuth potassium citrate 240 mg, clarithromycin 500 mg, amoxicillin 1000 mg, and rabeprazole 20 mg, twice daily for 14 days) in naive patients of H. pylori infection. The study is conducted in 40 centers across China led by Professor Liya Zhou, Chief Physician of the Third Hospital of Peking University and Deputy Director of the Gastroenterology Section of the Chinese Medical Association.

The Independent Data Monitoring Committee (IDMC) of the clinical trial consists of a biostatistician and two clinical experts. The interim analysis was conducted based on initial enrolled 350 patients (50% of the initial estimated sample size) according the study protocol, statistical analysis plan and IDMC charter. The blinded interim data indicated that the overall safety of the two study arms is acceptable in treating H. pylori infection with no serious adverse events (SAE) related to the experimental drugs occurred. The blinded overall H. pylori eradication rate is 90%. The IDMC reviewed the unblinded data and formed its opinion. There is no need to terminate the trial early due to lack of efficacy, no need to terminate the trial early due to safety concerns, no uncertainties that require suspension of enrollment, no need to modify the protocol before continuing the trial, and no need to increase sample sizes. Ultimately, IDMC recommended continuing the trial as planned.

Rifasutenizol is a new molecular entity with a novel multi-targeting mechanism of action. It exhibits excellent activities against H. pylori clinical isolates resistant to currently available antibiotics and has the advantage of a low propensity for the development of antibiotic resistance. Rifasutenizol has potential to become the first novel antibacterial drug specifically developed for H. pylori infection. TenNor has the global intellectual property rights and has received qualified infectious disease product (QIDP) and fast track designations for rifasutenizol from the FDA. This product is also supported by the National Major New Drug Innovation Grant in China.

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 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.

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