Cempra To Present Full Data Set Of Phase 2 Clinical Trial Of CEM-101

Trade CEMP now with

3/31/2012 1:33 AM ET

Cempra Inc. (CEMP: Quote) said that data will be presented at the European Congress of Clinical Microbiology and Infectious Diseases or ECCMID, in London, demonstrating CEM-101's efficacy to be comparable to levofloxacin in a Phase 2 trial of patients with community-acquired bacterial infections or CABP.

The phase 2 clinical trial of the study also showcases olithromycin's favorable safety and tolerability profile compared to levofloxacin, the company added.

Solithromycin is the first fluoroketolide with a number of attributes that may provide clinically important advantages over several comparator products.

Prabhavathi Fernandes, chief executive officer of Cempra commented "This is the first time that the full data set of this Phase 2 trial has been available for review by the infectious disease community. The promising results of this clinical trial will now be the basis for the initiation of our Phase 3 program in CABP. We expect to begin the first Phase 3 trial evaluating oral solithromycin in moderate-to-moderately severe CABP patients in the second half of 2012."

The CEO stated " Additionally, we are planning Phase 3 trials for 2013 testing the efficacy of intravenous-to-oral step down administration of solithromycin in moderate-to-severe CABP."

In a separate press release, the clinical-stage pharmaceutical company noted that data will be presented at the ECCMID demonstrating that CEM-101 (solithromycin) would be active against antibiotic-resistant strains of N. gonorrhoeae.

Magnus Unemo, associate professor, National Reference Laboratory for Pathogenic Neisseria said "In vitro studies, including the presentation at ECCMID, have indicated that solithromycin can be a promising agent for treating patients with gonococcal infections. N. gonorrhoeae is becoming a serious public health problem because current antibiotic options are gradually becoming less effective in treating the disease. New options are required and solithromycin appears to be a promising candidate."

To receive FREE breaking news email alerts for Cempra, Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

<<Previous 343 Articles

Editors Pick

Japan Upgrades Economic View Amid Export Recovery

The Japanese government on Monday upgraded its assessment of the economy for the first time in two months, as a weak yen helped revive the country's exports and factory output. "The Japanese economy is picking up slowly," the Cabinet Office said in its May monthly report. This was an upgrade from previous month's assessment when it said that economy was showing signs of picking up.

Upbeat Economic Data Contributes To Rally On Wall Street - U.S. Commentary

Stocks moved sharply higher over the course of the trading day on Friday, more than offsetting the weakness seen on Thursday. In a reversal from the previous session, the markets benefited from some upbeat U.S. economic data as well as comments from a Federal Reserve official. The major averages saw further upside going into the close, with the Dow and the S&P 500 reaching new record highs.

PETA: IRS Targeting Neither New Nor Limited To Conservative Causes

As the IRS targeting scandal continues to make headlines, animal-protection charity People for the Ethical Treatment of Animals, or PETA, claims that conservative groups are not the only ones that have faced increased scrutiny from the agency.