Fidaxomicin, an experimental antibiotic to treat Clostridium difficile Infection (CDI), has been shown safe and effective in comparative studies with Vancocin, Optimer Pharmaceuticals, Inc announced.
Fidaxomicin data from the second of two pivotal Phase 3 trials conducted in approximately 100 clinical sites involving 535 adult subjects throughout North America and Europe, showed that 91.7% of patients treated with fidaxomicin achieving clinical cure vs. 90.6% for Vancocin.
Vancocin is currently the only US FDA-approved therapy for Clostridium difficile Infection (CDI).
Optimer Pharmaceuticals plans to use data from this study to support submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2010, the company said in a press release.
“The robust results from our second Phase 3 trial of fidaxomicin confirm the results of our first Phase 3 trial showing that fidaxomicin has the potential to be a first-in-class drug for the treatment of Clostridium difficile infection,” stated Michael N. Chang, Ph.D., Optimer’s Chief Executive Officer.
Fidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the death of C. difficile.
The narrow-spectrum profile of fidaxomicin may eradicate C. difficile selectively with minimal disruption to the normal intestinal flora, while most broad-spectrum antibiotics, including metronidazole and vancomycin, disrupt these flora.
Fidaxomicin may facilitate the return of the normal physiological conditions in the colon and reduce the probability of CDI recurrence.
The second fidaxomicin Phase 3 trial and the first fidaxomicin Phase 3 trial are the two largest comparative studies ever conducted against Vancocin in CDI.
In November 2008, Optimer reported positive data from the first Phase 3 trial, which showed that fidaxomicin met its primary endpoint of non-inferiority of clinical cure compared to Vancocin.
In addition, patients treated with fidaxomicin in the first Phase 3 trial also experienced a reduction in CDI recurrence compared to Vancocin and had a higher global cure compared to Vancocin. The first Phase 3 study was conducted at sites throughout North America.
Clostridium difficile infection is a serious illness caused by infection of the inner lining of the colon by C. difficile bacteria, which produces toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop Clostridium difficile infection from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, and thus allowing C. difficile bacteria to flourish.
Clostridium difficile infection has become a significant medical problem in hospitals, long-term care facilities, and in the community.
Current therapeutic options for Clostridium difficile infection include the off-label use of metronidazole and oral vancomycin, the only FDA-approved treatment. However, approximately 20% to 30% of Clostridium difficile infection patients who initially respond to these treatments experience a clinical recurrence following cessation of antibiotic administration.
Primary risk factors for Clostridium difficile infection include broad-spectrum antibiotic use (such as cephalosporins and fluoroquinolones), advanced age (over 65) and emerging hyper-virulent strains (BI/NAP1/027, 078, 001) of C. difficile. Increasing incidence, higher treatment failures and recurrence with current therapies have resulted in greater awareness and concern of Clostridium difficile infection among medical professionals and public health officials.
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing anti-infective products to treat serious infections.
Optimer has two late-stage anti-infective product candidates under development. Fidaxomicin, formerly known as OPT-80, is the only antibiotic therapy currently in Phase 3 worldwide clinical development for Clostridium difficile infection.
Pruvel (prulifloxacin) is an antibiotic which has completed two Phase 3 clinical trials for the treatment of infectious diarrhea in travelers.