Everest Medicines Announces that Licensing Partner Venatorx Pharmaceuticals Reports Positive Results from Pivotal Phase 3 Cefepime-Taniborbactam Trial
Everest Medicines (HKEX 1952.HK) announced today that its licensing partner, Venatorx 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.EU(Nyheter)
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.”
Source: Everest Medicines