The Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services has announced that it will provide a $16 million dollar grant to clinical-stage pharmaceutical company Cempra, Inc. Cempra will use the BARDA grant to fund its clinical trials for the company’s intravenous, oral capsule, and oral suspension formulations of solithromycin for the treatment of bacterial pneumonia and other infections in pediatric patients.
Cempra, which is developing antibiotics for the treatment of bacterial infectious diseases, expects to receive the funding under the terms of a contract already established with BARDA, and it will be used specifically for the phase 1b, 2, and 3 development of solithromycin, which is an investigational, fourth generation macrolide antibiotic.
“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,” said the president and chief executive officer of Cempra, Prabhavathi Fernandes, Ph.D.
“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,” he added.
Cempra is now ready to begin its phase 1b clinical trials, for which they will enroll 64 pediatric patients. The patients will be administered oral capsules, oral suspension, or intravenous solithromycin according to their weight once a day for up to five days, which will be added to their standard therapy. In the open label study, researchers will use the pharmacokinetics in the pediatric population of the study as a primary endpoint, but they will also be collecting safety data as well.
The company had already completed phase 1a trials with patients between the ages of 12 and 17 years old, and demonstrated that the oral capsules were well tolerated and that its pharmacokinetic profile was similar to the one verified in adults. The patients were given solithromycin oral capsules for up to five days in addition to their standard treatments for a series of infections, such as sinusitis, exacerbations of cystic fibrosis, or other skin and soft tissue infections.
The phase 1a trials were also supported by a $17.7 million grant from BARDA, which comprised its initial funding from the five year contract established in May, 2013. The new agreement will fund the further evaluation and development of solithromycin for the treatment of bacterial infections in pediatric populations and infections caused by bioterror threat pathogens — particularly anthrax and tularemia.