Everest MedicinesVenatorx Pharmaceuticals, reported positive results from its pivotal Phase 3 study, CERTAIN-1 (Cefepime Rescue with Taniborbactam in cUTI), evaluating cefepime-taniborbactam, an investigational new drug, versus meropenem as a potential treatment for hospitalized adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis.
The CERTAIN-1 trial enrolled 661 adult patients globally, including China, who were randomized 2:1 to receive cefepime-taniborbactam 2.5g q8h or meropenem 1g q8h for 7 days (up to 14 days for patients with bacteremia). Cefepime-taniborbactam met the primary efficacy endpoint of statistical non-inferiority (NI) to meropenem in the microbiological intent-to-treat (microITT) population at Test of Cure (TOC) with composite microbiologic and clinical success occurring in 70.0% of cefepime-taniborbactam treated patients and 58.0% of meropenem treated patients (treatment difference 11.9; 95% CI, 2.4, 21.6). A prespecified superiority test following confirmation of NI demonstrated the statistical superiority of cefepime-taniborbactam for the composite endpoint at TOC. The superiority of cefepime-taniborbactam was sustained in the composite microbiologic and clinical response at the Late-Follow-Up (Day 28-35) visit.
Serious treatment-emergent adverse events (TEAEs) occurred in 2.0% and 1.8% of cefepime-taniborbactam and meropenem treated patients, respectively. Treatment discontinuations due to TEAEs were infrequent, occurring in 3.0% of cefepime-taniborbactam patients and 0.9% of meropenem treated patients. There was one death in the cefepime-taniborbactam arm of the study, which was deemed unrelated to study treatment by the investigator. Complete CERTAIN-1 study results will be presented at an upcoming scientific meeting.
Everest Medicines is developing cefepime-taniborbactam as a part of the global program in collaboration with Venatorx Pharmaceuticals. Under an exclusive licensing agreement with Venatorx Pharmaceuticals, Everest Medicines has the rights to develop and commercialize cefepime-taniborbactam in Mainland China, Hong Kong, Macau, Taiwan, South Korea, Indonesia, Malaysia, Philippines, Thailand, Singapore, and Vietnam.
"These data demonstrate that cefepime-taniborbactam may represent a significant improvement over the standard of care and could support global health efforts to combat antibiotic-resistant infections," said Christopher J. Burns, Ph.D., President and CEO of Venatorx. "Cefepime-taniborbactam, if approved by the FDA, may offer a new treatment option for higher-risk patients with infections caused by highly resistant bacteria, even those resistant to widely used carbapenem antibiotics. We want to thank the patients who enrolled in the trial, the clinical investigators who participated in the study, as well as our employees and partners, like Everest, for their steadfast support and determination to bring life-saving cures to patients around the world. We plan to submit a New Drug Application with the FDA for cefepime-taniborbactam for the treatment of cUTI in hospitalized adult patients later this year."
"We are very excited to see the encouraging results in the pivotal global Phase 3 study, and look forward to bringing this drug to patients in Asia," said Sunny Zhu, Chief Medical Officer for Infectious Diseases at Everest Medicines. "We continue to be committed to developing novel therapies for severe infectious diseases for patients in China and other parts of Asia with urgent needs."
About Cefepime and Taniborbactam
Cefepime, a fourth-generation cephalosporin, is a widely used beta-lactam (BL) antibiotic with more than two decades of proven safety and clinical utility against susceptible gram-negative and gram-positive bacteria. Taniborbactam is a beta-lactamase inhibitor (BLI) that, in combination with cefepime, may offer a potential treatment option for patients with serious bacterial infections caused by difficult-to-treat resistant gram-negative bacteria, most notably carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA). Many of these organisms are also multidrug-resistant (MDR), further limiting treatment options. Cefepime-taniborbactam has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the U.S. Food and Drug Administration.
About Complicated Urinary Tract Infections (cUTIs)
cUTIs, which include acute pyelonephritis, are defined as urinary tract infections ascending from the bladder accompanied by local and systemic signs and symptoms, including fever, chills, malaise, flank pain, back pain, and/or costovertebral angle pain or tenderness, that usually occur in the presence of a functional or anatomical abnormality of the urinary tract or in the presence of catheterization. Bacteremia can arise secondary to acute systemic infections like cUTI and can result in substantial morbidity and mortality.[i]
About CERTAIN-1 (Cefepime Rescue with Taniborbactam in cUTI)
CERTAIN-1 was a global, randomized, double-blind, active-controlled non-inferiority Phase 3 study evaluating the efficacy, safety, and tolerability of cefepime-taniborbactam compared to meropenem in adults with cUTI, including acute pyelonephritis. The trial enrolled 661 adult patients who were randomized 2:1 to receive cefepime-taniborbactam 2.5g q8h or meropenem 1g q8h for 7 days (up to 14 days for patients with bacteremia). The primary efficacy endpoint evaluated the composite clinical and microbiologic response (i.e., bacterial eradication) at the Test of Cure (TOC) visit (Day 19-23) in the microbiological intent-to-treat (microITT) population as specified by U.S. Food and Drug Administration and European Medicines Agency guidance.
About Venatorx Pharmaceuticals, Inc.
Venatorx Pharmaceuticals is a private, clinical-stage pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections. Venatorx's lead program, cefepime-taniborbactam, is a clinical-stage intravenous antibiotic that completed a Phase 3 study in adults with complicated urinary tract infections. Based on positive results from the CERTAIN-1 Phase 3 clinical trial, the Company expects to file a New Drug Application with the U.S. Food and Drug Administration for cefepime-taniborbactam in the fourth quarter 2022. For more information about Venatorx and its anti-infectives portfolio Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products 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 of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eleven 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 oncology, autoimmune disorders, cardio-renal diseases, and infectious diseases