TenNor Therapeutics has announced positive results from its Phase III clinical trial evaluating rifasutenizol for the treatment of Helicobacter pylori (H. pylori) infection. The trial demonstrated that rifasutenizol-based triple therapy achieved an eradication rate exceeding 90%, surpassing the efficacy of the current standard of care, bismuth-containing quadruple therapy (BQT). This outcome could mark a significant advancement in the treatment of this common bacterial infection.
The multicenter, randomized, double-blind, controlled trial (NCT05857163) compared the efficacy and safety of rifasutenizol triple therapy to BQT in patients with H. pylori infection. The study's primary endpoint was the eradication rate of H. pylori.
Superior Efficacy and Safety Profile
The Phase III trial results indicated that rifasutenizol triple therapy not only achieved a higher eradication rate than BQT but also exhibited a more favorable safety and tolerability profile. The dropout rate in the rifasutenizol arm was only 3%, suggesting better patient adherence and fewer adverse events compared to the BQT regimen.
Addressing Antibiotic Resistance
The study also highlighted the growing concern of antibiotic resistance in H. pylori strains. Resistance rates to clarithromycin, metronidazole, levofloxacin, and amoxicillin were 41%, 68%, 35%, and 8%, respectively, consistent with other reports indicating increasing antimicrobial resistance in China. Rifasutenizol targets anaerobic and microaerophile bacteria, potentially offering a solution to overcome existing resistance mechanisms.
Potential for a New Treatment Paradigm
TenNor Therapeutics believes that rifasutenizol has the potential to become the first new drug developed specifically for H. pylori infection in more than 30 years. The company has previously completed seven in-human clinical trials in China and has received Qualified Infectious Disease Product (QIDP) and fast track designations from the US Food and Drug Administration (FDA), underscoring the unmet need for novel H. pylori therapies.
