NEW YORK (GenomeWeb News) – Curetis and Cempra today announced a collaboration for the use of Curetis' Unyvero molecular diagnostic system in Cempra's phase III trial for its oral drug for community-acquired bacterial pneumonia.
Cempra expects to enroll more than 800 patients for the trial, which will compare its solithromyrin oral formulation against a comparator drug in more than 100 clinical sites globally. Samples of sputum will be sent to Curetis for analysis with its Unyvero Solution and Unyvero P50 Pneumonia Application Cartridge.
The Unyvero system has been developed for the detection of a broad panel of bacteria and antibiotic resistances. The CE-marked Unyvero P50 Pneumonia Application Cartridge focuses on pneumonia testing and simultaneously analyzes 39 DNA targets.
Data generated by Curetis will be paired with clinical and traditional microbiology data "to enhance the pathogen diagnosis rate in the trial," which is expected to begin in the fourth quarter of this year, the firms said. Enrollment is expected to be completed in 2014.
As part of the agreement, Curetis and Cempra can use the generated data for their own product development and for regulatory filings.
"The trial should provide us with an excellent opportunity to generate further data on the clinical sensitivity and specificity of our Unyvero solution in a commercially important indication, which is not yet included in the EU label, nor the one we are currently seeking in the US," Curetis CEO Oliver Schacht said in a statement. "Moreover, we hope to demonstrate the benefit of the Unyvero solution in an ambulant setting and also generate additional data from frozen samples."
"Improving diagnostic accuracy for the detection of pathogens causing pneumonia is critical to improving the management of these patients," David Oldach, senior vice president of clinical research for Cempra, said. "Curetis’ Unyvero assay will enhance the trial’s pathogen and resistance gene detection significantly, and positions our joint effort at the cutting edge of translational clinical science."
Curetis is a molecular diagnostics company based in Holzgerlingen, Germany. Founded in 2007, it raised €34.1 million ($41.9 million) last year in a Series A financing round.
Headquartered in Chapel Hill, NC, Cempra is a clinical stage pharmaceutical firm.