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news.The Medicines Company announced enrollment of the first patient in its Phase 3 clinical trial program for CARBAVANCE (meropenem/RPX7009), an investigational intravenous antibiotic under development for the treatment of serious bacterial infections due to gram-negative bacteria, particularly KPC (Klebsiella pneumoniae carbapenemase)-producing carbapenem-resistant Enterobacteriaceae (CRE).
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CARBAVANCEis a combination of the carbapenem antibiotic, meropenem, combined with RPX7009, the first of a novel class of beta-lactamase inhibitors. Beta-lactamase inhibitors are agents that inhibit bacterial enzymes, which destroy beta-lactam antibiotics and result in resistance to first line as well as "last defense" antimicrobials used in hospitals.
Gram-negative bacterial infections are widely considered to be one of the largest areas of unmet medical need, as these pathogens are growing increasingly resistant to existing therapies with few antibiotics in development.
"We are excited to be initiating our two clinical trials with CARBAVANCE," said Jeff Loutit, Vice President and Chief Medical Officer for Infectious Disease Care at The Medicines Company.
"RPX7009 was developed specifically to have activity against KPC producing strains of CRE, and meropenem is a carbapenem with a proven track record of efficacy and safety. We believe CARBAVANCE, upon approval, has the potential to provide health care professionals and patients with a new option for the treatment of serious gram-negative infections."
The first CARBAVANCE clinical trial is designed to evaluate the efficacy, safety and tolerability of CARBAVANCE in approximately 850 patients with complicated urinary tract infections (cUTI) or acute pyelonephritis (AP). The second trial is designed to evaluate the safety, efficacy and tolerability of CARBAVANCE in approximately 150 patients with suspected or known serious infections due to CRE across multiple indications.
Antibiotic resistance in gram-negative bacteria has increased markedly in the last decade, leaving clinicians and critically-ill patients few choices for treatment. The CDC has designated CRE as an urgent antimicrobial resistance threat. This has created an urgent need for new agents that has been recognized worldwide by health authorities.
"With acute and intensive care hospitals around the world facing rapid and increasing antibacterial resistance, the development of CARBAVANCE is the type of innovation we need as physicians to address such a threat," stated Keith S. Kaye, M.D., M.P.H., Professor of Internal Medicine and Infectious diseases at Wayne State University School of Medicine, Corporate Director of Infection Prevention, Hospital Epidemiology and Antimicrobial Stewardship at the Detroit Medical Center.
In January 2014, the U.S. Food and Drug Administration (FDA) designated CARBAVANCE as a Qualified Infectious Disease Product (QIDP). The QIDP designation provides CARBAVANCE priority review by the FDA, eligibility for the FDA’s "fast track" status, and an additional five years of exclusivity upon approval of the product for intravenous use in six indications.
These include complicated urinary tract and intra-abdominal infections, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia, and febrile neutropenia. The QIDP designation was granted pursuant to the Generating Antibiotic Incentives Now (GAIN) Act, included in the FDA Safety and Innovation Act (FDASIA) that was signed into law in 2012.
In February 2014, the CARBAVANCE program, through our subsidiary Rempex Pharmaceuticals, was awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) that included an initial commitment of $19.8 million and subsequent option periods over 5 years that, if completed, would bring the total value of the award to approximately $90 million to support the development of CARBAVANCE.
On October 30, 2014, BARDA awarded Rempex the second option, bringing the total commitment to date by BARDA to $37.8 million. The BARDA contract (HHSO100201400002C) is a cost-sharing arrangement that includes non-clinical development activities, clinical studies, manufacturing, and associated regulatory activities designed to gain US approval of CARBAVANCE for treatment of serious gram-negative infections. Studies are also planned to assess the potential usefulness of CARBAVANCE for treatment of certain gram-negative bioterrorism agents.