Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) announced that the company has completed enrollment in the first of two pivotal phase 3 clinical trials examining the safety and efficacy of prulifloxacin for the treatment of travelers' diarrhea. Travelers' diarrhea is characterized by diarrhea along with other related symptoms including nausea, vomiting, abdominal pain or cramping, and fecal urgency.
"Completing patient enrollment for this first trial is an important milestone in Optimer's Prulifloxacin development program," said Michael N. Chang, Ph.D., CEO and President of Optimer. "We look forward to completing the analysis of the data from this trial."
This multi-center, double-blind, randomized and placebo-controlled clinical trial compares the safety and efficacy of prulifloxacin versus placebo in adult travelers suffering acute bacterial gastroenteritis. Clinical trial sites included locations in the U.S., Mexico and Peru. The primary endpoint is time-to-last-unformed-stool. Secondary endpoints include clinical cure based on relief of symptoms and microbiological eradication rates.
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, currently in two pivotal Phase 3 clinical trials, is being developed for the treatment of Clostridium difficile infections, the most common hospital-acquired diarrhea. Prulifloxacin, also in two pivotal Phase 3 clinical trials, 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.
Forward-looking Statements
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 prulifloxacin and the timing of clinical trials and anticipated results thereof. 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.
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