Company News: Curetis’ Unyvero System Selected for Global Phase III Antibiotics Trial

Unyvero to be used for pathogen identification and patient inclusion at several clinical sites across Europe

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that Curetis’ Unyvero System will be used in a Phase III trial of a novel formulation of the antibiotic Amikacin. Unyvero was chosen as a platform to detect pathogens and antibiotic resistances in patients to be enrolled at intensive care units at several clinical trial sites across multiple European countries. Unyvero will be used to support patient identification and help boost enrollment rates at these sites.

Amikacin is an aminoglycoside antibiotic marketed for the treatment of severe, hospital-acquired infections with multidrug-resistant Gram-negative bacteria. The trial is evaluating the efficacy of a novel drug-device combination as an adjunctive therapy for Gram-negative pneumonia in the treatment of intubated and mechanically ventilated adult patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics. The trial is recruiting approximately 650 patients at trial sites worldwide.

Under the terms of the agreement with the sponsor of the trial, Curetis will deliver Unyvero systems and CE-IVD marked P55 cartridges to the trial sites as well as install the systems and provide training and technical support at these sites. The sponsor will fully reimburse Curetis for systems, training, services and consumables. Further financial details were not disclosed.