Venatorx Gears Up for FDA Approval after Antibiotic Clears Phase 3

Venatorx Pharmaceuticals is preparing to head to the FDA after its antibiotic for complicated urinary tract infections (cUTI) cleared a pivotal Phase 3 trial. 

The investigational drug, cefepime-taniborbactam, has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the U.S. Food and Drug Administration (FDA).

Development of the antibiotic started with federal funds from the National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services and Wellcome Trust. Funding continues support from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority,

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Certain-1 Meets Primary Endpoint

Cefepime-taniborbactam topped placebo in the Certain-1 randomized, double-blind Phase 3 study which assessed the safety and efficacy of the drug in adults with cUTI, including acute kidney infection. 

661 adult patients took part in the trial, which randomized them 2:1 to a one-week course of cefepime-taniborbactam 2.5g thrice daily or meropenem 1g thrice daily. 

The drug met the primary endpoint of bacterial eradication and non-inferiority to meropenem, which was taken at the Test of Cure visit from Day 19 to 23. 

70% of patients treated with the drug showed complete eradication, compared to 58% in the meropenem placebo group.   

On the safety end, the rates of adverse reactions to cefepime-taniborbactam was 35.5% compared to 29.0% for meropenem. Serious side effects occurred in 2.0% and 1.8% in the experimental versus control group. Meanwhile, 3.0% of patients treated with cefepime-taniborbactam discontinued treatment, compared to 0.9% in the meropenem group. There was also one death in the cefepime-taniborbatam group, which was unrelated to the treatment according to the investigator. 

“Cefepime-taniborbactam, if approved by the FDA, may offer a new treatment option for patients with infections caused by highly resistant bacteria, even those resistant to widely used carbapenem antibiotics,” said Christopher Burns, CEO of Venatorx. “We plan to submit a New Drug Application with the FDA for cefepime-taniborbactam for the treatment of cUTI in adult patients later this year.”

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Combination of Beta-Lactam and Beta-Lactamase Inhibitor

The investigational drug is a combination of a cefepime, a beta-lactam (BL), and taniborbactum, a beta-lactamase inhibitor (BLI). 

BL are small molecules that bind to enzymes required for bacterial cell wall synthesis, disrupting their formation. Sometimes, BLs are not enough, as bacteria would produce beta-lactamases to break down the BLs and inactivate the antibiotic. That’s where BLIs come in as insurance for BLs, inhibiting the beta-lactamases and enabling BLs to function. 

Cefepime in particular is a fourth-generation cephalosporin and widely-used BL antibiotic that targets gram-positive and gram-negative bacteria. Taniborbactum offers a way to bypass multidrug resistance commonly seen in bacteria such as carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA). 

AMR and cUTIs

According to the US Centers for Disease Control and Prevention (CDC), 2.8 million antimicrobial resistant (AMR) infections occur annually in the US, and directly causes more than 35,000 drug deaths. 

At the rate AMR infections are increasing, there may be 10 million deaths per year by 2050 – more than the projected 8.2 million caused by cancer. This highlights the need for better antibiotics that can overcome AMR. 

In cUTI, infection occurs in the urinary tract, which could ascend from the bladder to the kidney, causing symptoms such as fever, chills, back pain, and feeling unwell. Bacteremia could arise from cUTI, contributing to morbidity and mortality. More than 3 million cUTI patients may require antibiotics that would cost the healthcare system over $6 billion in annualized 30-day costs. 

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Joy Lin

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