|
Optimer Pharmaceuticals today announced that the company has completed enrollment in the first of two pivotal Phase 3 clinical trials evaluating the safety and efficacy of OPT-80 for the treatment of Clostridium difficile infection, or CDI
SAN DIEGO, CAM, USA | July 23, 2008 | Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR - News) today announced that the company has completed enrollment in the first of two pivotal Phase 3 clinical trials evaluating the safety and efficacy of OPT-80 for the treatment of Clostridium difficile infection, or CDI.
“Currently, there are limited treatment options for CDI. Completing enrollment in our first OPT-80 trial is a significant step in the development of OPT-80 as an innovative therapy which may help address the global CDI health crisis,” said Michael N. Chang, Ph.D., CEO and President of Optimer. “We look forward to analyzing and disclosing the data from this trial in the coming months.”
OPT-80, also known as PAR-101, is a first in-class narrow spectrum antimicrobial agent with excellent activity against many clostridia, including C. difficile, and moderate activity against certain gram-positive bacteria.
OPT-80, with its narrow spectrum profile, may eradicate C. difficile selectively with minimal disruption to the normal intestinal flora. This may facilitate the return of the normal physiological condition in the colon and reduce the probability of CDI recurrence.
OPT-80 Phase 3 Clinical Study Design
At the present time, the only FDA-approved antibiotic for the treatment of CDI is oral vancomycin. In the OPT-80 multi-center, randomized, double-blind clinical trial, the safety and efficacy of oral OPT-80 (200 mg q12h) is being compared to that of oral vancomycin (125 mg q6h) in subjects suffering from CDI. The study was designed to evaluate safety and compare the response to treatment by subjects during and after a 10-day course of therapy for cure, which is the primary endpoint. If cured, subjects are followed for a subsequent four-week period to evaluate recurrence, which is the secondary endpoint.
Significant Unmet Medical Need
CDI has become a significant 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.
Approximately 20% and 30% of CDI patients who initially respond to oral vancomycin and metronidazole, respectively, experience a clinical recurrence following the cessation of antibiotic administration.
Higher incidence and severity of CDI, increased treatment failures with standard therapies, and the emergence of the hypervirulent BI/NAP1/027 strain of C. difficile have combined to result in greater awareness of CDI and significant concern among medical professionals and public health officials.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products for the treatment of serious infections. Optimer has two late-stage anti-infective product candidates. OPT-80 is being developed for the treatment of Clostridium difficile infection, the most common hospital-acquired diarrhea. Prulifloxacin is an antibiotic being developed for the treatment of travelers’ diarrhea, a form of infectious diarrhea. Additional information regarding Optimer can be found at http://www.optimerpharma.com.
SOURCE: ptimer Pharmaceuticals, Inc. |
