New study calls for new treatments for carbapenem-resistant Enterobacteriaceae infection

Researchers at The Medicines Company presented data from a multi-national cohort that demonstrates the mortality and morbidity, and poor outcomes, associated with current therapies in patients with infections due to carbapenem-resistant Enterobacteriaceae (CRE).

The data from this analysis has guided the design of the company’s on-going clinical studies of its Phase 3 compound, CARBAVANCE® (meropenem/RPX7009) and was presented at the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy and Infection (ICC) joint meeting in San Diego, CA.

Jeff Loutit, MBChB, Vice President and Chief Medical Officer in the Infectious Disease Global Innovation Group at The Medicines Company, said:

Clinicians face limited antibiotic choices in treating CRE and the outcomes in these patients are very poor. The high mortality rate and poor clinical and microbiological cure rates illustrate the extremely poor efficacy of currently available therapies in this highly comorbid patient population.”

According to the U.S. Centers for Disease Control and Prevention (CDC), CRE is one of the three most urgent antimicrobial resistance threat pathogens, making this gram-negative bacteria an immediate public health threat that requires urgent and aggressive action.

CRE infections are spreading in healthcare facilities throughout the United States and the world. CRE bacteria have become resistant to all or nearly all first-line antibiotics available today, including carbapenems, which are often used due to resistance to other antimicrobials, particularly in the treatment of serious infections.

The analysis was conducted in patients with severe infections due to CRE to assess outcomes with current treatment options (“best available therapy”) and to guide the design of the Company’s on-going clinical studies of CARBAVANCE® (meropenem/RPX7009).

“Our analysis has shown that patients with CRE infections are very ill, with multiple comorbid conditions that often exclude them from clinical trials,” said Elizabeth Alexander, MD, Director of Clinical Development at The Medicines Company and lead investigator on the study. “This analysis has informed us on the planning and execution of our Phase 3 study of CARBAVANCE® in this patient population.”

The study titled, Designing Clinical Trials for New Agents in CRE Infection: What is “Best Available Therapy” in CRE and How Well Does it Work?, reviewed the treatment of 257 adult patients at 22 major medical centers in the U.S., the U.K., Italy and Greece over a six-month period. Patients with complicated urinary tract infection (cUTI), acute pyelonephritis (AP), hospital acquired bacterial pneumonia (HABP), ventilator associated bacterial pneumonia (VABP), or bacteremia due to CRE pathogens were included in the analysis.

There was a high morbidity and mortality rate among the patients, with a 28-day mortality of 28% that was highest in patients with hospital-acquired (35%) and ventilator-associated (33%) bacterial pneumonia, and lowest among in patients with cUTI/AP (18%). Only 57% of patients achieved a clinical cure and just over half (52%) achieved microbiological eradication.

The U.S. Centers for Disease Control (CDC) has listed CRE as an urgent public health threat. An estimated 140,000 healthcare-associated Enterobacteriaceae infections occur in the United States each year and about 9,300 are caused by CRE. However, even for critical pathogens like CRE, there is not a complete picture of the domestic incidence, prevalence, mortality, and cost of resistance1.

“The Medicines Company is committed to developing and commercializing solutions to address a variety of serious and urgent antimicrobial resistance threats, such as CRE,” said Michael Dudley, PharmD, Senior VP and Head, Health Science R&D, and Co-Leader of the Infectious Diseases Global Innovation Group at The Medicines Company. “This analysis points to the urgent need for more treatment options and study of new agents in patients with CRE.”

Source: The Medicines Company

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