Curetis AG and Cempra Inc. announced a research and development collaboration to incorporate Curetis’ Unyvero molecular diagnostic system into Cempra’s upcoming global Phase 3 trial of the oral formulation of solithromycin in patients with community-acquired bacterial pneumonia (CABP).
Under the terms of the agreement, each party may use the generated data for its own product development and for its regulatory filings.
Cempra’s randomized, double-blind Phase 3 trial comparing solithromycin against a comparator drug is expected to enroll over 800 patients in more than 100 clinical sites worldwide. Sputum samples from patients will be sent to Curetis for analysis with its Unyvero Solution and the CE-marked Unyvero P50 Pneumonia Application Cartridge. Molecular diagnostic data generated from the Unyvero Solution will be paired with clinical and traditional microbiology data to enhance the pathogen diagnosis rate in the trial. The trial is expected to start during the fourth quarter of 2012 and enrollment is expected to be completed in 2014.
“The collaboration with Cempra, which is developing much-needed novel antibiotics to overcome the resistance problem, is a perfect strategic fit for us,” said Oliver Schacht, PhD, chief executive officer of Curetis AG. “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 U.S. Moreover, we hope to demonstrate the benefit of the Unyvero solution in an ambulant setting and also generate additional data from frozen samples.”
David Oldach, MD, senior vice president of clinical research of Cempra said, “Improving diagnostic accuracy for the detection of pathogens causing pneumonia is critical to improving the management of these patients. 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.”
Prabhavathi Fernandes, PhD, president and chief executive officer of Cempra added, “We believe that rapid and accurate identification of infectious pathogens will enable the better selection of appropriate antibiotic therapy and reduce the overuse of antibiotics.”
Date: August 9, 2012
Source: Curetis AG
Filed Under: Drug Discovery