Monday, April 19, 2010

Positive results from second phase 3 Study of Fidaxomicin for the treatment of Clostridium difficile Infection..

Fidaxomicin  is the first in a new class of narrow spectrum macrocyclic  antibiotic drugs.  It is non-systemic (minimally absorbed into the bloodstream)  bactericidal, and  has demonstrated selective eradication of pathogenic Clostridium difficile with minimal disruption to the multiple species of bacteria that make up the normal, healthy intestinal flora. The maintenance of normal physiological conditions in the colon can reduce the probability of clostridium difficile infection recurrence.

Now Optimer Pharmaceuticals, Inc.,  announced the top-line results from its second fidaxomicin Phase 3 clinical study in patients with Clostridium difficile infection (CDI) at the 20th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna, Austria. 

As per the claim by the company, in the trial, fidaxomicin met the primary endpoint of non-inferiority in clinical cure compared to Vancocin®.  Importantly, fidaxomicin also had significantly lower recurrence rates compared to Vancocin (p = 0.002), and significantly higher global cure rates (defined as cure with no recurrence within four weeks of completing therapy) compared to Vancocin (p < 0.001).  Interestingly  the se robust results from this second fidaxomicin Phase 3 trial confirm the results from the first fidaxomicin Phase 3 trial.  Together these trials enrolled more than 1,100 subjects thus making them the two largest comparative studies ever conducted against Vancocin in CDI.

"Fidaxomicin offers potential advantages over existing therapies as a single agent that can provide a high cure rate and fewer recurrences for Clostridium difficile infection," said Dr. Crook, M.D., Consultant Microbiologist/Infectious Diseases and Professor of Infectious Diseases and Microbiology, Experimental Medicine Division, Nuffield Department of Clinical Medicine (NDM), University of Oxford"...  

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