Optimer Pharmaceuticals Announces Peer. Hospital trials.
SAN DIEGO–(BUSINESS WIRE)–April 2, 2008 - Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced the pamphlet of its Phase 1 clinical trials of OPT-80 in the April 2008 copy 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 abide the situation of OPT-80 as an vocal analysis 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 dissertation highlights some time ago reported statistics from a Phase 1a single-dose and a Phase 1b multiple-dose irritant of OPT-80 for the curing of CDI. Four lone voiced doses of OPT-80 (100, 200, 300, and 450 mg) were administered to fit volunteers in a double-blinded, placebo-controlled Phase 1a study. In the double-blinded Phase 1b study, salutary subjects were randomized to welcome OPT-80 (150, 300, or 450 mg) or placebo for 10 days.
In both studies, OPT-80’s sanctuary and tolerability were evaluated and the concentrations of OPT-80 and its germinal metabolite, OPT-1118, were identified in plasma and feces. At daytime ten for the 450 mg per light of day multiple-dose group, the have in mind OPT-80 stool concentration exceeded 10,000 times the MIC(90) (minimum concentration of a narcotize needed to hold back enlargement 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 side-view for CDI treatment. CDI is a pensive bug caused by infection of the inner lining of the colon by C. difficile, bacteria that bring forth toxins resulting in inflammation, violent diarrhea and, in not joking cases, death. CDI is a significant refractory in hospitals, long-term worry facilities and in the community. C. difficile is the most common cause of nosocomial diarrhea.
The creature accounts for approximately 20 percent of cases of Antibiotic-associated diarrhea and many of the cases of Antibiotic-associated colitis. The rising occurrence of CDI has been attributed to the reiterative recipe of broad-spectrum Antibiotics and the fleet develop of a hypervirulent quality of the C. difficile bacteria. OPT-80 Overview OPT-80, hitherto known as PAR-101 or Difimicin, is a beginning in-class parsimonious spectrum antimicrobial go-between with champion occupation against many clostridia including C. difficile and ease action against unspecified gram-positive bacteria.
OPT-80, with its near spectrum profile, may eradicate C. difficile selectively with token disruption to the regular intestinal flora. This may promote the render of the customary physiological adapt in the colon and rub the chance of CDI recurrence. About Optimer Pharmaceuticals Optimer Pharmaceuticals, Inc. is a biopharmaceutical throng focused on discovering, developing and commercializing innovative anti-infective Products for the therapy of momentous infections.
Optimer has two late-stage anti-infective merchandise candidates. OPT-80, currently in two crucial Phase 3 clinical trials, is being developed for the remedying of Clostridium difficile infection, the most Joint hospital-acquired diarrhea. Prulifloxacin, also in two urgent Phase 3 clinical trials, is an Antibiotic being developed for the Care of travelers’ diarrhea, a appear of transmissible diarrhea. Additional communication with reference to Optimer can be found at http://www.optimerpharma.com. Forward-looking Statements Statements included in this subject to announcement that are not a characterization of reliable facts are forward-looking statements, including without limitation All statements Joint to prevalence of CDI and the occurrence of OPT-80.
Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “goal” and comparable expressions are intended to tag forward-looking statements. The classification of forward-looking statements should not be regarded as a replica by Optimer that any of its plans will be achieved. Actual results may be contradictory in the long run from those set forth in this notice due to the risks and uncertainties connate in Optimer’s enterprise including, without limitation, risks relating to: the timing, way and probability of triumph of its consequence inspect and evolvement programs, the timing and significance of its preclinical and clinical advance of covert drugs and Other risks exhaustive in Optimer’s filings with the Securities and Exchange Commission.
Opinion site: click
Related posts
Tags: clinical, diarrhea, difficile, optimer, phase, statements