2020-02-26| Trials & Approvals

EXBLIFEP Surpasses Phase III, Presents Novel Solution for Antibiotic Resistance Crisis in Treating Complicated UTI

by Ruchi Jhonsa
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By Ruchi Jhonsa, Ph.D.

Urinary tract infections (UTI) are some of the most common bacterial infections, affecting 150 million people each year globally. Although most are treatable, complicated UTI is tougher to overcome and predominantly occurs due to a preexisting abnormality in the urinary tract. It can also manifest due to a compromised immune response in the body. Currently, the annual societal costs of these infections, including healthcare costs and time missed from work, are approximately $3.5 billion. Besides, UTIs are a significant cause of morbidity in infant boys, older men, and females of all ages. Currently, the best method to treat UTIs is through antibiotics. However, its frequent use and misuse have spiked antibiotic resistance in microbes, a phenomenon that is emerging as one of the biggest healthcare challenges of the 21st century. This calls for the development of a new class of antibiotics that functions through novel mechanisms.


EXBLIFEP, a Novel Extended-Spectrum β-lactamase Inhibitor

Over the last two decades, there has been a rise in antibiotic resistance with very few innovations in development. In an effort to tackle this issue, Allecra Therapeutics has announced positive results for its investigational candidate, EXBLIFEP in the phase III ALLIUM clinical trial in patients with complicated UTI. The drug met the FDA and EMA pre-specified primary endpoint in addition to demonstrating superiority over the existing drug, Piperacillin-tazobactam.

EXBLIFEP is a combination of enmetazobactam, a novel extended-spectrum beta-lactamase inhibitor belonging to penicillin acid sulfone class and cephalosporin cefepime, an antibiotic. EXBLIFEP has been given a Qualified Infectious Disease Product and Fast Track Designation that provides the company with 5 years of market exclusivity and faster FDA review.

Keith Kaye M.D., MPH, Professor of Medicine and Director of Research for Infectious Diseases at the University of Michigan shared his concerns about the rising bacterial infections. “Infections from ESBL-producing Enterobactericeae have increased in the US since 2000 and now also cause infection in the community. According to the most recent U.S. Centre for Disease Control and Prevention (CDC) data 197’400 cases of ESBL-producing Enterobacteriaceae occur every year with 9’100 associated deaths. The use of piperacillin-tazobactam for the treatment of such infections has been controversial, and the development of new treatments for these infections has been classified as a critical priority by the World Health Organization (WHO). Cefepime-enmetazobactam combination may provide a novel therapeutic option addressing this serious threat” he said.


The Phase III ALLIUM Trial

The ALLIUM trial is a multi-center, randomized, controlled, double-blind, global study that compared cefepime (2g)/enmetazobactam (0.5g) to piperacillin (4g)/tazobactam (0.5g) in 1034 patients who were randomly given either drug combo every 8hrs as 2hrs continuous intravenous infusion. The resolution of UTI symptoms and reduction in bacterial count below 1000 CFU/ml in the urine were defined as primary endpoints. The primary efficacy evaluation was performed in the microbiological Modified Intent-to-Treat Population, which included patients infected with a Gram-negative pathogen deemed non-resistant to both drug combinations. EXBLIFEP showed positive results in the trial with an overall success of 79.1% vs 58.9% for piperacillin-tazobactam. Generally, EXFLEBIP was well tolerated with 4.3% of patients reporting serious adverse events, which was similar to piperacillin-tazobactam (3.7%).

EXBLIFEP’s superiority over existing drug provides a novel therapeutic option for treatment of UTI. “The superiority demonstrated in the primary endpoint, at test of cure, combined with a comparable safety profile to that of well tolerated and widely used piperacillin-tazobactam support the potential use of cefepime-enmetazobactam as a new empiric and carbapenem-sparing treatment for multi-drug resistant Gram-negative infections” said Patrick Velicitat M.D., CMO of Allecra Therapeutics.

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