Optimer Pharmaceuticals to present fidaxomicin Phase 3 clinical trial data at ICAAC Conference

Sep 15 2010

Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) announced the presentation of new data from its North American and European fidaxomicin Phase 3 clinical trials in patients with Clostridium difficile infection (CDI) at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston.  During an oral presentation, investigator Oliver Cornely, M.D., of the University of Cologne, presented data showing that fidaxomicin was superior to vancomycin in treating a CDI recurrence and in reducing the chance of another relapse.

CDI recurrence occurs in approximately 25% of patients treated with existing therapies and there is no agreement in the medical community on the optimal treatment for a recurrence.  In the two fidaxomicin Phase 3 trials, a separate stratum was constructed of subjects who had experienced a prior CDI episode and recurred within three months of entering the study.  The 178 subjects with recurrent CDI  were randomized to be treated with either fidaxomicin or vancomycin and 128 of these subjects were subsequently evaluable for recurrence within the study. Following treatment, 35.5% (22/62) of the subjects who received vancomycin experienced another recurrence compared to 19.7% (13/66) among the subjects who received fidaxomicin>

"The Phase 3 trials previously showed that fidaxomicin is superior to vancomycin in the prevention of recurrence.  The data presented today show that fidaxomicin is also superior to vancomycin in the treatment of CDI patients suffering a recurrence," said Sherwood Gorbach, Optimer's Chief Medical Officer and Senior Vice President of Medical Affairs.  "This is an important finding given that the medical community has not found a successful and reliable treatment for recurrent CDI.  With our recent MAA filing and anticipated NDA filing, we continue to work diligently to make fidaxomicin available to the medical community for treating acute CDI and for preventing and treating recurrences."