Cempra's Solithromycin Demonstrates Safety and Tolerability in Patients With Chronic Liver Disease

Pharmacokinetic Analyses of Hepatic Impairment Study Show no Dosage Adjustments Necessary to Compensate for Decreased Liver Function

        Print
| Source: Cempra, Inc.

CHAPEL HILL, N.C., Sept. 5, 2013 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced 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, M.D., senior director of clinical research at Cempra. "Based on the pharmacokinetic analyses, no dosage adjustments were needed in these patients with mild to severe chronic liver disease. Solithromycin continues to differentiate itself against current treatments for community-acquired bacterial pneumonia, sexually-transmitted diseases and other serious infections."

In this 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 (CABP), to evaluate both the safety and efficacy in this patient population.

"Solithromycin, our differentiated molecule, has shown a favorable safety profile throughout its clinical testing to date in healthy volunteers and in CABP patients," said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. "We believe that the U.S. Food and Drug Administration's requirements for the CABP safety database will be met through our Phase 3 clinical trials and previous studies."

About Cempra, Inc.

Founded in 2006, Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases. Cempra's two lead product candidates are currently in advanced clinical development. Solithromycin (CEM-101) is in a Phase 3 clinical trial for community-acquired bacterial pneumonia (CABP) and is licensed to strategic partner Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. TAKSTA™ (CEM-102) is Cempra's second product candidate currently in a Phase 2 clinical trial for prosthetic joint infections. Both seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. The company also intends to use its series of proprietary lead compounds from its novel macrolide library for uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Additional information about Cempra can be found at www.cempra.com.

Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the results, timing, costs and regulatory review, and other analyses, of our studies and clinical trials; our need to obtain additional funding and our ability to obtain future funding on acceptable terms; our anticipated capital expenditures and our estimates regarding our capital requirements; our ability to obtain FDA approval of our product candidates; our dependence on the success of solithromycin and Taksta; and innovation by our competitors. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.

Investor and Media Contacts:
Robert E. Flamm,
Ph.D. Russo Partners, LLC
(212) 845-4226


Andreas Marathovouniotis
Russo Partners LLC
(212) 845-4235