Curetis will provide Cempra with clinical sample testing on its Unyvero™ molecular diagnostic system for use as part of the latter’s pending Phase III trial evaluating an oral formulation of its solithromycin antibiotic in patients with community-acquired bacterial pneumonia. The comparator-based solithromycin study will enroll over 800 patients at over 100 clinical sites worldwide, and is expected to start before the end of this year.
Sputum samples from patients will be sent to Curetis for analysis on the recently CE-marked Unyvero system and Unyvero P50 pneumonia application cartridge. Resulting molecular diagnostic data will be combined with clinical and microbiology data to improve the pathogen diagnosis rate in the trial.
“The collaboration with Cempra, which is developing much-needed novel antibiotics to overcome the resistance problem, is a perfect strategic fit for us,” comments Oliver Schacht, Ph.D., Curetis CEO. “This 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.”
Curetis’ Unyvero point of care diagnostic platform and P50 pneumonia cartridge were granted CE mark in May. The automated assay is designed to simultaneously test for 39 DNA targets from a range of pneumonia-causing bacteria and determine antibiotic resistance.
Cempra’s solithromycin is an orally active, broad-spectrum fluoroketolide antibiotic. In June the firm started dosing patients in a Phase II study evaluating the drug in the treatment of uncomplicated urogenital gonococcal infections, including those caused by antibiotic-resistant Neisseria gonorrhoeae.