Additional Data From Fidaxomicin's Phase 3 Study for Clostridium Difficile Infection (CDI) Presented at IDSA Annual Meeting
SAN DIEGO, Oct. 31 Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced the presentation of new data from fidaxomicin's North American phase 3 study at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Philadelphia, PA.
Mark A. Miller, M.D., head of the Division of Infectious Diseases, Chair of the Infection Prevention and Control Unit at the Jewish General Hospital in Montreal, Quebec, Canada, presented results showing that fidaxomicin is associated with faster resolution of diarrhea. In patients with more pronounced diarrhea (ie. not resolving in the first 24 hours of therapy), fidaxomicin was associated with a faster time to resolution of diarrhea than vancomycin (79 hours vs. 105 hours, p=0.056). It is possible that decreasing the duration of diarrhea may have a direct impact on reducing the spread of CDI in healthcare facilities and lowering overall environmental spore contamination, thereby decreasing CDI rates and leading to earlier discharge of CDI patients from the hospital.
In another presentation, Kathleen M. Mullane, D.O., an investigator from the University of Chicago, Department of Medicine, Section of Infectious Diseases, in Illinois, presented data that indicated fidaxomicin may be a more effective therapy for CDI in patients requiring concomitant antibiotics. Treatment of CDI is often complicated by systemic infections requiring concomitant antibiotics. The analysis indicated that in patients receiving concomitant antibiotics, those treated with fidaxomicin versus vancomycin, had a significantly improved global cure rate (72% vs. 50%, p=0.022), lower CDI recurrence rate (40% vs. 23%, p=0.061), and higher clinical cure rate (87% vs. 77%, p=0.171).
"The faster time to resolution of diarrhea and improved outcomes for patients requiring concomitant antibiotics are important factors for physicians to consider when selecting a treatment for CDI," said Michael N. Chang, Ph.D., President and CEO of Optimer Pharmaceuticals. "These additional factors along with the significantly lower recurrence rate and higher global cure rate suggest that fidaxomicin has the potential to be a best in class therapy for CDI."
For a complete list of posters, please visit the Resources webpage on our web site at www.optimerpharma.com.
Fidaxomicin Clinical Study Design
629 adult subjects were enrolled in this multi-center, randomized, double-blind phase 3 clinical trial, which was the largest such trial for the treatment of CDI. Subjects with confirmed CDI received either 200 mg fidaxomicin dosed orally twice daily or 125 mg Vancocin dosed orally four times daily. This study was conducted in more than 100 clinical sites throughout North America. The objective of the study was to show that a 10-day course of fidaxomicin was at least as efficacious (non-inferior) and safe as a 10-day course of Vancocin (vancomycin hydrochloride capsules, USP) for the treatment of CDI.
The primary endpoint of the study was clinical cure defined as patients requiring no further CDI therapy two days after completion of study medication, as determined by the investigator. The secondary endpoint evaluated CDI recurrence up to four weeks post therapy with recurrence defined as the return of diarrhea associated with CDI confirmed by a positive toxin test. Global cure was defined as patients who were cured and did not have a recurrence.
About Clostridium Difficile Infection
CDI has become a growing problem in hospitals, long-term care facilities and in the community. It is a serious illness caused by infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. CDI typically develops from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, allowing C. difficile bacteria to flourish.
Current therapeutic options for CDI include metronidazole and oral vancomycin. However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of antibiotic administration.
Primary risk factors for CDI include broad-spectrum antibiotic use, advanced age (over 65), emerging hyper-virulent strains (BI /NAP1/027, 078, 001) of C. difficile, and previous exposure to CDI that lead to recurrence. Higher incidence, increased treatment failures, and recurrence with standard therapies have resulted in greater awareness and concern of CDI among medical professionals and public health officials.
About Fidaxomicin (OPT-80)
Fidaxomicin is the first in a new class of antibiotics called macrocyclics, which inhibit the bacterial enzyme RNA polymerase, resulting in the death of Clostridium difficile. The narrow spectrum profile of fidaxomicin may eradicate Clostridium difficile selectively with minimal disruption to the normal intestinal flora. This may facilitate the return of the normal physiological conditions in the colon and reduce the probability of CDI recurrence.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products to treat serious infections and address unmet medical needs. 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(TM) (prulifloxacin) is an antibiotic which has completed two Phase 3 clinical trials for the treatment of infectious diarrhea in travelers. Additional information can be found at http://www.optimerpharma.com.
Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to the ability of fidaxomicin to treat CDI, address current treatment limitations and reduce the incidence of CDI. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to: the timing, progress and likelihood of success of its product research and development programs, the timing and status of its preclinical and clinical development of potential drugs and other risks detailed in Optimer's filings with the Securities and Exchange Commission.
Contacts Optimer Pharmaceuticals, Inc. John Prunty, CFO & VP, Finance Christina Donaghy, Corporate Communications Manager 858-909-0736 Porter Novelli Life Sciences Jason I. Spark, Vice President 619-849-6005
SOURCE Optimer Pharmaceuticals, Inc.
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