Curetis will use its recently approved Unyvero intra-abdominal infection (IAI) cartridge diagnostic to test patients enrolled in the Biotest’s PEPPER Pentaglobin® Peritonitis Trial for IAIs and for antibiotic resistance markers.
The Phase IIb PEPPER trial is evaluating the immune-modulating effects of Biotest’s marketed Pentaglobin® immunoglobulin M (IgM) enriched immunoglobulin in patients with secondary peritonitis. The study, conducted at 12 centers across Germany and Austria, is sponsored by RWTH Aachen University. Under terms of the deal with Biotest, Curetis will use the Unyvero IAI platform to carry out in-house testing services on 200 native ascites samples and an equal number of matched positive blood culture samples from the same patients.
“”The PEPPER trial is designed to investigate strategies to personalize immune-modulating approaches in patients with septic shock after postoperative secondary peritonitis,” said Jörg Schüttrumpf, M.D., head of R&D at Biotest. “With an overall mortality of up to 30%, this condition is one of the most fatal diseases on intensive care units. The Unyvero IAI application will provide us with a highly standardized and rapid way to identify the pathogens in the patients enrolled in the PEPPER trial that we are supporting.”
Curetis’ Unyvero IAI Cartridge was granted a CE mark in April. The diagnostic is designed for the rapid diagnosis of IAIs, including peritonitis, cholecystitis, and acute pancreatitis, using samples including tissue, ascites in positively flagged blood cultures, and gastric juice. The Unyvero IAI Cartridge can test for up to 92 bacteria, 13 fungi, 3 toxins, and 22 resistance markers and covers pathogens including Clostridium difficile, Clostridium perfringens, Aeromonas spp., as well as hard-to-cultivate anaerobic strains.
“We are very pleased that only a few months after market launch of the CE-marked Unyvero IAI Cartridge, Biotest has chosen our solution for this important trial,” said Achim Plum, Ph.D., CCO of Curetis. “With Sanofi, Cempra, and the Phase III Amikacin trial, Biotest is now the fourth pharmaceutical company using our cartridges in clinical trials to diagnose and stratify patients.”
The Unyvero IAI cartridge is the fourth diagnostic developed for the Unyvero platform, and follows on from the pneumonia, implant, and tissue infections (ITI) and BCU bloodstream infection test cartridges. Curetis says it is also developing additional panels for diagnosing severe urinary tract infections and sepsis host response, along with expanded panels in respiratory diseases and cardiology-related infections.
In April, Curetis established a wholly owned Ares Genetics subsidiary. The new business is leveraging the GEAR (Genetic Antibiotic Resistance and Susceptibility Database) and assets acquired from Siemens, to identify new drug resistance biomarkers and targets for antimicrobial drugs.
Based near Frankfurt, Germany, Biotest is a fully integrated supplier of plasma protein products and developer of biotherapeutics for applications in immunology, hematology, and intensive care medicines. In June, the firm agreed to be taken over by China’s Creat Group.