Date: 2014-11-19
Type of information: Grant
Company: Cempra (USA - NC)
Investors: Biomedical Advanced Research and Development Authority (USA)
Amount: $16 million
Funding type: grant
Planned used: The funds will be used for two clinical studies of solithromycin. Pediatric patients from newborn to age 17 years who are enrolled in the study may receive intravenous, oral suspension or oral capsule formulations of solithromycin, an investigational, fourth generation macrolide antibiotic. In a recently completed Phase 1a study conducted in pediatric patients age 12 to 17 years, solithromycin oral capsules were well tolerated and demonstrated a pharmacokinetic profile similar to that seen in adults. The Phase 1b portion of the 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. On-going with this program, as part of this funding is the optimization of the commercial pediatric suspension product and the company is expected to begin the start-up activities for a global Phase 2/3 study.
Others: * On November 19, 2014, Cempra, a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, announced it has received authorization under its existing contract for the next phase of its contract with the Biomedical Advanced Research and Development Authority (BARDA) that will provide funding of $16.0 million for two clinical studies of solithromycin. Initial funding from BARDA of $17.7 million supported the Phase 1a clinical study that enrolled pediatric patients between the ages of 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. In May 2013 , Cempra entered into a five year agreement with the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services (Contract No. HHS0100201300009C) for the evaluation and development of solithromycin for the treatment of bacterial infections in pediatric populations and infections caused by bioterror threat pathogens, specifically anthrax and tularemia. The BARDA agreement 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.
Therapeutic area: Infectious diseases
