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news.Optimer Pharmaceuticals (Optimer) has reported positive top-line results from the second of two pivotal Phase 3 trials evaluating the safety and efficacy of Fidaxomicin (OPT-80) in patients with Clostridium difficile Infection (CDI).
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The study was conducted in approximately 100 clinical sites throughout North America and Europe. The company plans to use data from the study to support submission of a New Drug Application (NDA) to the FDA in the second half of 2010.
Reportedly, the trial met the primary endpoint of non-inferiority with 91.7% of patients treated with Fidaxomicin (per protocol population) achieving clinical cure vs 90.6% for Vancocin, the only FDA-approved therapy for CDI.
Additionally, Fidaxomicin also had lower recurrence rates and higher global cure rates compared to Vancocin. Only 12.8% of patients treated with Fidaxomicin experienced a recurrence vs 25.3% of patients treated with Vancocin. 79.6% of patients treated with Fidaxomicin achieved a global cure versus 65.5% of patients treated with Vancocin. As in the first Phase 3 trial, Fidaxomicin was well-tolerated in the study.
Earlier, in November 2008, the company has 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.
Michael Chang, CEO at Optimer, said: “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. There are currently limited treatment options for this disease and we believe there is a need for innovative alternatives.
“A higher global cure demonstrates the potential for Fidaxomicin to improve patient outcomes, reduce repeat visits to the hospital and reduce person-to-person transmission, which may result in a lower cost burden to the healthcare system.”