Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced the commencement of two Phase III clinical studies in collaboration with Japan’s Meiji Seika Pharma. These studies are focused on their co-developed anti-infective, Nacubactam (OP0595), which is being tested in combination with cefepime or aztreonam for the treatment of adult aerobic Gram-negative bacterial infections where treatment options are limited.
One of the Phase III studies aims to evaluate the efficacy and safety of Nacubactam (OP0595) when combined with cefepime or aztreonam in adults with complex urinary tract infections or acute simple pyelonephritis. The second study will assess the same combination therapy in a range of complex infections, including urinary tract infections, acute simple pyelonephritis, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and complex abdominal infections caused by carbapenem-resistant Escherichia coli in adults.
OP0595 is a novel intravenous β-Lactamase inhibitor under development for the treatment of adult aerobic Gram-negative bacterial infections, particularly those caused by carbapenem-resistant Escherichia coli, where traditional treatment options are limited. It is currently in a Phase I clinical study in China, investigating its use in combination with cefepime or aztreonam for the same patient population.- Flcube.com
