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Optimer Pharmaceuticals Announces Peer-Reviewed Publication of OPT-80 Phase 1 Clinical Results for the Treatment of Clostridium Difficile Infection

Posted on: Wednesday, 2 April 2008, 09:00 CDT

Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced the publication of its Phase 1 clinical trials of OPT-80 in the April 2008 edition of Antimicrobial Agents and Chemotherapy published by the American Society for Microbiology. The article is entitled, "Safety, Tolerance and Pharmacokinetic Studies of OPT-80 in Healthy Volunteers Following Single and Multiple Doses" (AAC April 2008; v. 52: 1391-1395). The results from these studies support the development of OPT-80 as an oral therapy for Clostridium difficile infection, or CDI. OPT-80 is currently being tested in Phase 3 clinical trials for CDI, also known as Clostridium difficile-associated diarrhea.

The paper highlights previously reported data from a Phase 1a single-dose and a Phase 1b multiple-dose trial of OPT-80 for the treatment of CDI. Four single oral doses of OPT-80 (100, 200, 300, and 450 mg) were administered to healthy volunteers in a double-blinded, placebo-controlled Phase 1a study. In the double-blinded Phase 1b study, healthy subjects were randomized to receive OPT-80 (150, 300, or 450 mg) or placebo for 10 days. In both studies, OPT-80's safety and tolerability were evaluated and the concentrations of OPT-80 and its primary metabolite, OPT-1118, were determined in plasma and feces. At day ten for the 450 mg per day multiple-dose group, the mean OPT-80 stool concentration exceeded 10,000 times the MIC90 (minimum concentration of a drug needed to inhibit growth of 90 percent of microorganisms) of C. difficile. In both the single-dose and the multiple-dose studies, OPT-80 was well tolerated by all subjects and no drug-related adverse events were observed. Optimer believes that in the Phase 1 studies, OPT-80 also exhibited a favorable pharmacokinetic profile for CDI treatment.

CDI is a serious illness caused by infection of the inner lining of the colon by C. difficile, bacteria that produce toxins resulting in inflammation, severe diarrhea and, in serious cases, death. CDI is a significant problem in hospitals, long-term care facilities and in the community. C. difficile is the most common cause of nosocomial diarrhea. The organism accounts for approximately 20 percent of cases of antibiotic-associated diarrhea and many of the cases of antibiotic-associated colitis. The rising incidence of CDI has been attributed to the frequent prescription of broad-spectrum antibiotics and the rapid spread of a hypervirulent strain of the C. difficile bacteria.

OPT-80 Overview

OPT-80, formerly known as PAR-101 or Difimicin, 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.

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 infection, 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 incidence of CDI and the development of OPT-80. 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.

Source: Business Wire

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