Company News: Curetis Partners with Biotest to support academic PEPPER Pentaglobin® Peritonitis Trial with Unyvero IAI Application

— Trial sponsored by University Clinic RWTH Aachen investigates personalized treatment approaches with Biotest’s Pentaglobin® in peritonitis patients

— Curetis to provide testing services for different samples from up to 200 patients with its recently launched Unyvero IAI Application for intra-abdominal infections

Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that it has closed a partnership with Biotest AG (Dreieich, Germany). Under the terms of the agreement, Curetis will provide Biotest with in-house testing services using Curetis’ Unyvero IAI cartridge for the diagnosis of intra-abdominal infections. Financial terms were not disclosed.

Curetis’ services will comprise testing for microbial pathogens (bacteria and fungi), toxins, and antibiotic resistance markers for the clinical trial PEPPER (Personalized Medicine with Pentaglobin® after surgical source control in patients with peritonitis). PEPPER is a multicentric, two-arm Phase IIb study to test the immune-modulating effect of Pentaglobin®, an IgM enriched immunoglobulin marketed by Biotest, in patients with secondary peritonitis. The clinical trial is being sponsored by RWTH Aachen and conducted in 12 centers across Germany and Austria. Curetis will test approximately 200 native ascites samples and an equal number of matched positive blood culture samples from the same patients.

The Unyvero IAI Cartridge was launched in April this year and has been developed to support clinicians with the fast and reliable diagnosis of various severe conditions, including peritonitis, cholecystitis and acute pancreatitis. It covers up to 92 bacteria, 13 fungi, 3 toxins and 22 resistance markers, among them Clostridium difficile, Clostridium perfringens, Aeromonas spp. as well as difficult-to-cultivate strains such as Prevotella spp. that are often overlooked in the presence of aerobic / fast-growing microorganisms. It also comprises important antibiotic resistance markers such as Colistin resistance marker mcr-1, Fosfomycin resistance marker fosA3 and Nitroimidazol resistance markers nimA and nimB. Together with the Unyvero System, the IAI Cartridge can process a broad variety of clinical samples including tissue, ascites in positively flagged blood cultures, and gastric juice.

“The PEPPER trial is designed to investigate strategies to personalize immune-modulating approaches in patients with septic shock after postoperative secondary peritonitis,” said Dr. Jörg Schüttrumpf, Head of R&D of 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 which we are supporting.”

“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 Dr. Achim Plum, 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. This clearly underlines the value of the Unyvero System for the fast and reliable diagnosis of pathogens, antibiotic resistances and other important clinical markers in serious conditions.”