Cempra's Solithromycin Shows Safety, Tolerability In Liver Disease Patients

(RTTNews) - Cempra Inc. (CEMP), a clinical-stage pharmaceutical company, said Thursday that solithromycin demonstrated safety and tolerability in patients with mild to severe chronic liver disease.

The pharmacokinetic analyses also showed that no dosage adjustments to compensate for decreased liver function were necessary in this patient population.

"Solithromycin was well-tolerated in patients with chronic liver disease, both compensated and uncompensated, and no significant differences in safety from the age- and weight-matched healthy control group were observed," said Brian Jamieson, senior director of clinical research at Cempra.

"Solithromycin continues to differentiate itself against current treatments for community-acquired bacterial pneumonia, sexually-transmitted diseases and other serious infections."

In the hepatic impairment study, 24 patients with chronic liver disease, eight with mild disease, eight with moderate disease and eight with severe disease, were given a five-day course of solithromycin dosed as 800 mg on day 1 followed by 400 mg once-daily on days two through five. The pharmacokinetics of solithromycin in these three patient groups were evaluated and compared to a matched healthy control cohort given the same regimen.

Solithromycin is currently in a global Phase 3 clinical trial in patients with community-acquired bacterial pneumonia, to evaluate both the safety and efficacy in this patient population.