Optimer Pharmaceuticals Initiates Second Phase 3 Trial of OPT-80 for CDAD
- Category: Small Molecules
- Published on Wednesday, 02 May 2007 04:00
- Hits: 1874
SAN DIEGO, CA, USA | May 1, 2007 | Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) announced today that it has initiated a second Phase 3 registration trial of OPT-80 (PAR-101), formerly known as Difimicin, for the treatment of Clostridium difficile-associated diarrhea (CDAD). When patients are treated with broad-spectrum antibiotics, C. difficile can grow in the bowel, produce toxins, and cause severe diarrhea. CDAD is the primary cause of nosocomial diarrhea worldwide, affecting more than 500,000 patients in the U.S. In Europe, the overall incidence is estimated to be more than one out of every 1,000 patients hospitalized.
“Following the positive Data Safety Monitoring Board response in March, our OPT-80 development efforts continue to advance,” said Michael N. Chang, President and CEO of Optimer. “Starting this second pivotal Phase 3 trial is an important milestone for the Company. We are looking forward to submitting a New Drug Application to the FDA in 2008.”
The design of this second trial is identical to the on-going pivotal Phase 3 clinical trial and is a multi-national, double-blind, randomized, parallel group study to determine the safety and efficacy of OPT-80 versus Vancocin® (oral vancomycin) in subjects with CDAD. The primary endpoint is the clinical cure rate at the end of therapy and the secondary endpoint is recurrence within four weeks. A total of approximately 664 CDAD patients from approximately 100 clinical sites in Europe and North America will be enrolled in this international study.
OPT-80 (PAR-101), the Company’s lead antibiotic drug candidate is a new class of antibiotics for the treatment of CDAD. We believe that OPT-80 offers advantages over current treatments due to its superior activity against CDAD, low rates of recurrence, evidence of low CDAD resistance, minimal systemic exposure, limited disruption of normally occurring gastrointestinal bacteria and convenient dosing regimen. Our studies indicate that OPT-80 acts by inhibiting RNA polymerase, a bacterial enzyme, which results in the death of specific bacteria such as C. difficile.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products for the treatment of serious infections. For more Company information go to 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 OPT-80, Prulifloxacin, CDAD, and the timing of clinical trials. 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 our product research and development programs, the timing and status of our preclinical and clinical development of potential drugs and other risks detailed in Optimer's filings with the Securities and Exchange Commission.
SOURCE: Optimer Pharmaceuticals, Inc.