TenNor Therapeutics announced that its Phase III clinical trial of rifasutenizol, an antibiotic candidate, successfully met all primary endpoints, outperforming the current standard of care (SoC) for Helicobacter pylori (H. pylori) infection.
The multicenter, randomized, double-blind, controlled trial (NCT05857163) evaluated rifasutenizol triple therapy against bismuth-containing quadruple therapy (BQT) in eradicating H. pylori, a common bacterial infection of the stomach known to cause stomach ulcers. The study revealed that the rifasutenizol regimen achieved an eradication rate exceeding 90%, which is significantly higher than that of BQT.
Safety and Tolerability
In addition to its superior efficacy, the rifasutenizol regimen demonstrated a more favorable safety and tolerability profile compared to BQT. The trial reported a low dropout rate of only 3% among patients receiving rifasutenizol. Furthermore, there were no significant differences observed in demographics or baseline antibiotic resistance characteristics between the two treatment groups.
Antimicrobial Resistance
The study also highlighted the increasing problem of antimicrobial resistance among H. pylori strains. Patients treated with clarithromycin, metronidazole, levofloxacin, and amoxicillin exhibited resistance rates of 41%, 68%, 35%, and 8%, respectively. These findings, consistent with other reports, underscore the urgent need for new antibiotics and alternative therapies to combat the growing threat of antibiotic resistance.
Potential Impact of Rifasutenizol
Rifasutenizol, designed to target anaerobic and microaerophile bacteria, holds the potential to become the first new drug specifically developed for H. pylori infection in more than three decades. TenNor Therapeutics has previously completed seven in-human clinical trials in China and has been granted Qualified Infectious Disease Product (QIDP) and fast track designations by the US Food and Drug Administration (FDA).
