The Biomedical Advanced Research and Development Authority (BARDA) will provide funding of $16.0 million for two clinical studies of solithromycin, an investigational, fourth generation macrolide antibiotic, to Cempra, Inc.
The funding is the next phase of an existing 5-year contract with BARDA, and is based on positive results from a recently completed Phase 1a study conducted in pediatric patients age 12 to 17 years with suspected or confirmed bacterial infections.
Each patient received solithromycin oral capsules for up to five days as add-on therapy in addition to standard of care treatments for a variety of infections, including sinusitis, exacerbations of cystic fibrosis as well as skin and soft tissue infections.
Pharmacokinetics of the oral capsules in this age group were comparable to data from adult studies of solithromycin and it was well tolerated. Cempra has also reported positive results in treating tularemia and anthrax in non-clinical models which was also funded by BARDA in the first year of the contract.
“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,” stated Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra.
The new study will enroll up to 64 pediatric patients aged newborn to 17 years with suspected or confirmed bacterial infections. Patients will receive oral capsules, oral suspension or intravenous solithromycin dosed by weight once per day as add on therapy for up to 5 days. The study is open label and the primary endpoint will be to determine pharmacokinetics in the pediatric population. Safety data will also be collected.
The BARDA agreement with Cempra is a cost plus fixed fee development contract with a base performance segment plus four option segments. If all four option segments are requested, the total value of the agreement would be approximately $58.6 million with a period of service to 2018.
