Phase 2/3 Pivotal Trial Will Test Intravenous, Oral Capsule and Oral Suspension Formulations of Solithromycin in Pediatric Patients From Age 2 Months to 17 Years
Cempra to Receive $25.5 Million in Funding for the Next Phase of Its Existing Agreement With BARDA
CHAPEL HILL, N.C. , March 07, 2016 (GLOBE NEWSWIRE) — Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced it has received authorization under its existing contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, to receive funding of $25.5 million through mid-2018 for a Phase 2/3 clinical study of solithromycin. Cempra is responsible for an additional designated portion of the cost of the planned Phase 2/3 study. Pediatric patients from age 2 months to 17 years with community-acquired bacterial pneumonia (CABP) who are enrolled in the study may receive intravenous, oral suspension or oral capsule formulations of solithromycin, an investigational, fourth generation macrolide antibiotic, or a comparator treatment. The planned enrollment of 400 patients for the Phase 2/3 study is expected to begin during the first half of 2016, with full enrollment expected during the first half of 2018.