2023-05-20

Rifasutenizole for H. pylori Completed First Patient in of Phase III Clinical Trials in China

Suzhou, China, May 20, 2023 – TenNor Therapeutics (Suzhou) Limited announced that its investigational new drug Rifasutenizole (TNP-2198) for the treatment of Helicobacter pylori infection has completed the first patient in (FPI) of a multi-center phase III trials in China.

 

Rifasutenizole is a new molecule entity discovered and developed by TenNor specifically for the treatment of H. pylori infection. Its multi-targeting synergistic mechanism delivers low drug resistance frequencies, maintaining excellent bactericidal activities against H. pylori strains isolated from various regions. So far TenNor has completed five clinical trials in China, and the product has been approved the IND and Qualified Infectious Drug Product (QIDP) status by the US FDA. TenNor owns the global intellectual property of Rifasutenizole.`

 

TenNor is currently conducting a multi-center, randomized, double-blind, bismuth-containing quadruple therapy-controlled Phase III study to evaluate the efficacy and safety of Rifasutenizole in the primary treatment of patients with H. pylori infection. The primary investigator of the study is Professor Liya ZHOU, director of gastroenterology department at Peking University Third Hospital, vice chairman and leader of H. pylori study group at the digestive branch of the Chinese Medical Association. The study will serve as the pivotal study to support the NDA of Rifasutenizole in China.

 

Rifasutenizole has the potential to streamline the eradication regimes of H. pylori so as to improve the compliance and enable a seamless connection to the urea breath test (UBT), rendering the possibility of carrying out screening-eradication on large scale.

 

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.

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