Cempra Inc. announced on Thursday that is will receive an additional $16 million from the Biomedical Advanced Research and Development Authority (BARDA) for two more clinical studies of its drug solithromycin on pediatric patients with bacterial infections.
The antibiotic will be given to patients from newborn to 17 years old who are undergoing treatment for bacterial infectious diseases. Patients will be given the drug through an I.V., oral suspension or a capsule.
Initial funding of $17.7 million from BARDA supported Phase 1a of the study, Cempra said. In the first study, the drug was given to patients ages 12 to 17 years old.
"I am pleased with the progress we are making under our continuing collaborative and constructive BARDA relationship that has resulted in the approval of funding for the next phase of our investigational studies with solithromycin in pediatric patients that is expected to extend our indications," Prabhavathi Fernandes, president and chief executive officer of Cempra, said. "BARDA's continuing recognition of the potential of solithromycin to have broad utility in all age groups allows our pediatric program to run in parallel with our adult Phase 3 studies in adults with community-acquired bacterial pneumonia and in uncomplicated gonorrhea."
The Phase 1b study will include up to 64 patients with suspected or confirmed bacterial infections, whol will receive the antibiotic for up to five days.