–Cefepime-taniborbactam was superior to meropenem for the composite efficacy endpoint with composite efficacy sustained at late follow-up visit–
SHANGHAI, Feb. 21, 2024 /PRNewswire/ — Everest Medicines (HKEX 1952.HK)’s 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 Executive Officer of Everest Medicines. "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."
About CERTAIN-1
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.
Efficacy Data
Cefepime-taniborbactam met the prospectively defined non-inferiority primary endpoint of composite microbiologic and clinical response versus meropenem at the TOC visit (70.6% response rate for cefepime-taniborbactam versus 58.0% for meropenem). The prespecified superiority analysis at the TOC visit demonstrated that cefepime-taniborbactam was statistically superior to meropenem for the composite endpoint (response rate difference: 12.6% [95% confidence interval (CI): 3.1, 22.2]; p=0.009) and for the microbiologic endpoint (response rate difference: 11.7% [CI: 2.9, 21.0]); the clinical endpoint response rate difference was 4.5% [CI: -2.6, 12.6]. At the Late Follow-up (LFU) visit (Day 28-35), cefepime-taniborbactam demonstrated sustained statistical superiority to meropenem for the composite endpoint (63.8% response rate for cefepime-taniborbactam versus 51.7% for meropenem (response rate difference: 12.1% [CI: 2.2, 21.9]) and for the clinical response endpoint (response rate difference: 9.9% [CI: 1.5, 18.8); the microbiologic endpoint response rate difference was 7.7% [CI: -1.6, 17.3]. Additionally, cefepime-taniborbactam maintained a numerical advantage to meropenem against resistant pathogens: cefepime-resistant (71% response rate for cefepime-taniborbactam versus 53% for meropenem), ESBL-producing (71% response rate for cefepime-taniborbactam versus 55% for meropenem) and MDR (68% response rate for cefepime-taniborbactam versus 60% for meropenem).
Safety Data
Cefepime-taniborbactam demonstrated a safety profile consistent with meropenem. Treatment-emergent adverse events occurred in 35.5% and 29.0% of cefepime-taniborbactam and meropenem treated patients respectively. Serious adverse events occurred in 2.0% of cefepime-taniborbactam patients and 1.8% of meropenem treated patients. The most frequently reported treatment-emergent adverse events were headache (6.1% with cefepime-taniborbactam versus 3.7% for meropenem), diarrhea (4.1% versus 2.3%), and constipation (3.2% versus 1.4%). Three percent of patients treated with cefepime-taniborbactam discontinued therapy due to a treatment-emergent adverse event versus 0.9% of patients treated with meropenem. The safety data for cefepime-taniborbactam was consistent with the historical safety data for cefepime.
About Cefepime-Taniborbactam
Cefepime-taniborbactam is an investigational agent that is a combination of cefepime, a fourth-generation cephalosporin, and the novel beta-lactamase inhibitor (BLI), taniborbactam, that exhibits broad coverage of both serine- and metallo-beta-lactamases. In combination with cefepime, taniborbactam is under development as a new treatment option for patients with serious bacterial infections caused by difficult-to-treat drug resistant gram-negative pathogens, including carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant or multidrug-resistant Pseudomonas aeruginosa (CRPA/MDR-PA).
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company’s therapeutic areas of interest include renal diseases, autoimmune disorders, and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
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