Reinach, Switzerland, 26 October 2008 Arpida (SWX: ARPN) today presented the combined results from two pivotal Phase III clinical trials at the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/Infectious Diseases Society of America (IDSA) 46th annual meeting in Washington, DC. In these studies, intravenous iclaprim, a novel antibiotic, showed high clinical cure rates which were similar to those of the comparator drug, linezolid, in the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). In addition, iclaprim was well-tolerated with a safety profile that compared favorably to linezolid. A New Drug Application for intravenous iclaprim in cSSSI will be discussed at the meeting of the U.S. Food and Drug Administration Anti-Infective Drugs Advisory Committee on 20 November 2008.
Iclaprim, a novel antibiotic from the trusted dihydrofolate reductase (DHFR) selective inhibitor class of antibiotics, was specifically designed to address the growing need for additional treatment options to combat resistant infections including MRSA. MRSA affects more than 2 million people in the United States each year and rates of hospital- and community-acquired MRSA are on the rise. ,
"The high efficacy rates and favorable tolerability profile of iclaprim strongly supports its potential as a new treatment option for patients who have acquired serious infections caused by MRSA," said Dennis L. Stevens, MD, PhD, Veterans Affairs Medical Center, Boise, Idaho. "With rates of MRSA increasing and effectiveness of some current antibiotics declining, it is important to identify effective alternative treatments for these infections."
The results presented at the ICAAC/IDSA meeting were gathered from the ASSIST-1 and ASSIST-2, (Arpida's Skin and Skin Structure Infection STudy) pivotal Phase III studies involving a total of 991
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