AECB study stopped to consider exclusion of Ketek comparator.
Replidyne is temporarily stopping its Phase III trial in patients being treated for acute exacerbation of chronic bronchitis (AECB) due to the FDA’s concern over one of the comparison arms of the trail.
In a 17-to-2 vote, the FDA’s Advisory Committee found that in the study, which is comparing faropenem medoxomil (faropenem) to placebo and Ketek (telithromycin), an approved ketolide antibiotic, the risks of Ketek outweigh the benefits of using the drug for the treatment of patients with AECB.
Replidyne’s lead product candidate, faropenem medoxomil, is a novel oral community antibiotic under development for the treatment of respiratory and other community infections.
“We believe that stopping enrollment in this trial to consider the inclusion of Ketek in the study is the appropriate and responsible action at this time to consider the new scientific evidence presented at the recent FDA Advisory Committee meeting,” says Kenneth J. Collins, president and CEO of Replidyne. Collins expects that in spite of this delay, the company will be able to complete the clinical program to support the submission for the adult indications of acute bacterial sinusitis, community acquired pneumonia, and AECB as well as continue with the development of the pediatric clinical program.