MALVERN, PA — Venatorx Pharmaceuticals, Melinta Therapeutics LLC, and the Menarini Group recently celebrated a significant medical breakthrough with the publication of the CERTAIN-1 Phase 3 clinical study results in The New England Journal of Medicine. The investigational agent cefepime-taniborbactam outperformed meropenem in treating complicated urinary tract infections (cUTI) and acute pyelonephritis (AP), including cases accompanied by bacteremia.
The rise of antibiotic-resistant gram-negative infections, such as cUTIs, has posed significant hurdles to effective treatment. Gram-negative bacteria have developed resistance to multiple classes of antibiotics, causing increasing concern among medical practitioners. However, the recent Phase 3 study results suggest that cefepime-taniborbactam might offer a viable solution for treating a broad range of patients with cUTIs due to suspected or confirmed multidrug-resistant pathogens, including Enterobacterales and Pseudomonas aeruginosa.
“This Phase 3 study is the culmination of a long journey of discovery and development,” said Dr. Paul C. McGovern, Senior Vice President at Venatorx and co-author of the publication. “We look forward to progressing this agent through the next regulatory stages so that the drug may reach patients worldwide as expeditiously as possible.”
The CERTAIN-1 study was a randomized, multicenter, double-blind, active-controlled, non-inferiority investigation involving 661 hospitalized patients with cUTIs, including AP. The study compared the efficacy of cefepime-taniborbactam (2.5 g every 8 hours) to meropenem (1 g every 8 hours). The primary endpoint was the composite microbiologic and clinical response at the Test of Cure (TOC) visit (Day 19-23) in the microbiological intention-to-treat population. The study concluded that cefepime-taniborbactam was not only non-inferior to meropenem but superior, with a similar safety profile.
Melinta Therapeutics’ President and Chief Executive Officer, Christine Ann Miller, expressed her delight at the results, stating, “We look forward to leveraging our experience in marketing infectious disease products and our established commercial infrastructure, especially within the hospital and acute care settings, to make cefepime-taniborbactam available to physicians and their patients with complicated urinary tract infections if approved.”
Najy Alsayed, Global Therapeutic Area Head-Infectious Diseases at Menarini Group, highlighted the importance of the findings in the European context. “E.coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa are largely involved in cUTI Gram-negative pathogens infections reaching nearly 75% in Europe,” he said. The CERTAIN-1 Phase 3 data indicating cefepime-taniborbactam’s superiority provides useful insights for its expected contribution in the treatment of hospitalized patients with cUTI in Europe, upon approval by relevant regulatory authorities.
The promising results of the CERTAIN-1 Phase 3 study have industry watchers eagerly anticipating the next steps for cefepime-taniborbactam. If it successfully navigates the remaining regulatory stages, this drug could soon become a critical tool for healthcare providers in the fight against antibiotic-resistant gram-negative bacterial infections.
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