Everest Medicines (HKEX:1952.HK) has announced that its licensing partner, Venatorx Pharmaceuticals, reported positive results from a Phase 3 study investigating the use of cefepime-taniborbactam in hospitalized adults with complicated urinary tract infections (cUTI), including acute pyelonephritis.
The study pitted cefepime-taniborbactam against meropenem. First approved in 1996, meropenem is used to treat various bacterial infections.
In the Phase 3 CERTAIN-1 (Cefepime Rescue with Taniborbactam in cUTI) study, cefepime-taniborbactam met the primary efficacy endpoint of statistical non-inferiority (NI) to meropenem.
Cefepime is a commonly used beta-lactam (BL) antibiotic, while taniborbactam is a novel beta-lactamase inhibitor.
A total of 661 patients participated in the trial who were randomized 2:1 to receive cefepime-taniborbactam 2.5 g q8h or meropenem 1g q8h for seven days. Patients with bacteremia were treated for up to 14 days.
A total of 70.0% of cefepime-taniborbactam recipients had clinical success compared with 58.0% of patients treated with meropenem.
Venatorx intends to file a new drug application with the FDA for cefepime-taniborbactam to treat hospitalized adults with cUTI.
Everest has an exclusive licensing agreement with Venatorx to develop and commercialize cefepime-taniborbactam in Mainland China, Hong Kong, Macau, Taiwan, South Korea, Indonesia, Malaysia,
“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 in a statement. “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.”
Everest shares ticked up 1.57% to $19.38.
Venatorx Pharmaceuticals is privately held.