Everest Medicines Licensing Partner Venatorx Pharmaceuticals Announces Publication of Positive Results from Cefepime-Taniborbactam's Phase 3 CERTAIN-1 Study in New England Journal of Medicine
Cefepime-taniborbactam was superior to meropenem for the composite efficacy endpoint with composite efficacy sustained Everest Medicines licensing partner, Venatorx Pharmaceuticals announced that The New England Journal of Medicine (NEJM) published the results of the CERTAIN-1 Phase 3 clinical study of the investigational agent cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis. The results showed that cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a similar safety profile to meropenem.
•Gram-negative infections such as cUTI have become increasingly difficult to treat due to bacterial acquired resistance to multiple classes of antibiotics. Cefepime-taniborbactam has the potential to treat a broad range of patients with cUTI due to suspected or confirmed multidrug-resistant (MDR) pathogens,"" said Paul C. McGovern, MD, Senior Vice President at Venatorx and co-author of the publication.
• This Phase 3 study is the culmination of a long journey of discovery and development, and we look forward to progressing this agent through the next regulatory stages so that the drug may reach patients world-wide as expeditiously as possible.
•The publication of Phase 3 clinical data in the respected New England Journal of Medicine is a further testament of cefepime-taniborbactam's ability to address urgent and unmet medical needs in multidrug-resistant infections, said Rogers Yongqing Luo, Chief
• In Asia, the challenges we are facing from MDR infections are more urgent and severe. We are proud to have received priority review for the medicine in China and are preparing to submit a New Drug Application in the country this year.
• Together with our first launched product in the anti-infectious disease space, Xerava, we hope to save the lives of more patients with critical conditions from MDR infections.
• CERTAIN-1 was a randomized, multicenter, double-blind, active-controlled, non-inferiority study of hospitalized patients (N=661) with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), comparing 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 (microITT) population.
• The non-inferiority margin was -15% and there was a prespecified superiority analysis if non-inferiority was concluded.
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