Cempra, Inc received clearance to initiate Phase 1b and Phase 2 / 3 studies that will test their solithromycin antibiotic in newborn to 17 year-old patients. The experimental antibiotic could eventually offer new therapeutic options to cystic fibrosis patients in fighting bacterial lung infections.
Intravenous, oral suspension formulas, and oral capsules of solithromycin will be administered to study participants within the pediatric age range. This therapeutic is a fourth generation macrolide and an investigational antibiotic.
The Biomedical Advanced Research and Development Authority (BARDA) will provide funding to the two clinical assessments of solithromycin.
Recently, Cempra completed a Phase 1a study for solithromycin in order to test safety and efficacy in fighting infections. The antibiotic was given to patients between the ages of 12 to 17 years old. The outcomes show that solithromycin administered in oral capsules was well tolerated and its pharmacokinetic profile was very similar to what has been observed in adults.
“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 CEO of Cempra, Dr. 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.”
An initial $17.7 million in funding from BARDA supported the Phase 1a study, which specifically enrolled patients who had suspected or confirmed bacterial infections. Patients received oral capsules of solithromycin over five days as a complement to the standard care treatments for several infectious such as sinusitis, exacerbations of cystic fibrosis, and skin and soft tissue infections.
The Phase 1b trial will enroll 64 pediatric patients with confirmed or suspected infections caused by bacteria. According to their weight, an appropriate dosage will be delivered by intravenous methods, oral capsules or oral suspension for five days, once per day. Pharmacokinetics in this population and safety data will be assessed. The new BARDA award will also fund a global Phase 2/3 study of solithromycin, which will help to get the antibiotic one step closer to approval by health authorities worldwide.