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Everest Medicines announces positive data for investigational treatment for complicated urinary tract infections

By Brian Buntz | March 11, 2022

Everest/VenatorxEverest 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, Philippines, Thailand, Singapore, and Vietnam.

“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.

 


Filed Under: Infectious Disease
Tagged With: cefepime-taniborbactam, Everest Medicines, meropenem, Venatorx Pharmaceuticals
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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