Sep. 14, 2009 (PR Newswire) --
SAN DIEGO, Sept. 14 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced the presentation of results from its second prulifloxacin Phase 3 clinical study for the treatment of infectious diarrhea in travelers, by clinical investigator Robert Steffen, M.D., at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco.
(Logo: http://www.newscom.com/cgi-bin/prnh/20090413/LA97352LOGO)
Dr. Steffen presented the positive top-line results that the Company had previously announced in February 2009. The results showed that prulifloxacin met the study objective of superiority to placebo in the resolution of diarrhea, measured by Time to Last Unformed Stool (TLUS) in patients suffering from TD-associated pathogens such as E. coli, Salmonella, Campylobacter, and Shigella. Prulifloxacin showed a statistically significant benefit compared to placebo in TLUS in both the mITT (modified intent- to-treat; n=200) and microbiologically evaluable (per protocol; n=173) populations. The median TLUS for patients treated with prulifloxacin was 32.8 hours; this was significantly different from the TLUS for placebo with a p-value of <0.0001. The Company plans to file a new drug application (NDA) during the first half of next year.
"The high levels of efficacy demonstrated in this study, combined with the convenient dosing schedule, suggest that prulifloxacin has the potential to become a standard treatment for travelers' diarrhea," said Robert Steffen, M.D., primary investigator and head of the Division of Epidemiology and Prevention of Communicable Diseases at the University of Zurich, and Director of the World Health Organization Collaborating Center for Traveler's Health. "While several antibiotic-based treatment options are currently available, many fall short of treating the disease adequately due to limited antibacterial coverage, bacterial resistance and poor patient compliance."
To view the poster on prulifloxacin, please visit the Resources webpage on our website at www.optimerpharma.com.
Prulifloxacin Clinical Study Design
This study, referenced as OPT-099-002, was conducted at sites in India, Guatemala, and Mexico and evaluated adult travelers from industrialized countries suffering from infectious diarrhea. The patients were randomized (1:1) to receive either 600mg of prulifloxacin or placebo, once daily over three days. Stool specimens were collected before treatment and one to three days following the end of treatment to identify intestinal pathogens. The primary efficacy endpoint was Time to the Last Unformed Stool, which was defined as the time in hours from the first dose of study medication to the passage of the last unformed stool.
