Positive results from Cempra's IV solithromycin Phase 1 study
Published on October 8, 2012 at 10:21 AM
Cempra, Inc. (Nasdaq: CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced results of its Phase 1 study of intravenous (IV) solithromycin in healthy subjects. The study demonstrated that IV solithromycin was well tolerated, showed a favorable pharmacokinetic profile (PK) and achieved relevant plasma concentrations.
"Solithromycin is the first macrolide since azithromycin that has the potential to be administered both intravenously and orally," said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. "We believe that these data now position Cempra to initiate our IV-to-oral solithromycin Phase 3 trial when funding is in place. The availability of both intravenous and oral formulations of solithromycin would enable physicians to step-down therapy from IV to oral administration with the same antibiotic. A timely and appropriate switch to oral therapy is a significant goal of physicians and insurers, and can facilitate seamless discharge to outpatient care. This would be better both for the patient and the healthcare system."
Study subjects were administered doses of solithromycin, ranging from 25 to 800 mg, or placebo. No serious adverse events or significant QT prolongation episodes were observed. Among patients receiving repeated doses of 400 mg daily for up to seven days, no clinically significant systemic adverse events were observed, and the desired PK profile was achieved, with clinically relevant peak solithromycin concentrations of 4 micrograms/mL. Modeling of the PK data suggest that initial intravenous dosing with 400 mg once-daily, with a switch to oral administration at the same dose when clinically appropriate will achieve concentrations of the drug that warrant its evaluation in the treatment of moderate to severe community acquired bacterial pneumonia caused by pathogens including azithromycin-resistant pneumococcus, Legionella, Mycoplasma, Moraxella, Hemophilus influenzae, and community-acquired methicillin-resistant Staphylococcus aureus.