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Optimer Pharmaceuticals Initiates Phase 3 Clinical Trials of OPT-99 for the Treatment of Gastroenteritis

Posted on: Tuesday, 28 March 2006, 09:01 CST

Earlier this year, Optimer Pharmaceuticals, Inc., opened an IND (Investigational New Drug) with the Food and Drug Administration, for its late-stage anti-infective compound, OPT-99. Phase 3 clinical trials of OPT-99 for bacterial gastroenteritis are scheduled to begin in May 2006.

As a first indication, the Company plans to develop OPT-99 for the treatment of bacterial gastroenteritis including traveler's diarrhea. "We have chosen traveler's diarrhea as an indication for development because OPT-99 shows exceptional activity against and excellent coverage of the bacterial pathogens linked to this disease," stated Dr. Brian Walsh, Research Investigator at Optimer. "Moreover, OPT-99 offers other important advantages including a short three-day and convenient once-daily dosing regimen with an excellent safety profile."

Optimer plans to conduct two independent, international Phase 3 trials. Investigators will begin to enroll patients in mid-May 2006 in the United States, Mexico, and Peru; the second trial will soon follow in India and Africa. These pivotal gastroenteritis trials will be performed in collaboration with Advanced Biologics (www.advbiol.com , New Hope, PA) and under the guidance of Dr. Herbert Dupont (Director, Center for Infectious Diseases, University of Texas School of Public Health), who has studied this common ailment for over thirty years and is an international authority on infectious diseases and travel medicine. If successful, the Company hopes to file an NDA (New Drug Application) with the FDA as early as mid-2007.

OPT-99 is also known as prulifloxacin, which is the pro-drug of a novel fluoroquinolone antibacterial agent developed by Nippon Shinyaku Co., Ltd. Since 2002, the drug has been prescribed in Japan to treat a variety of bacterial diseases including respiratory and urinary tract infections, skin infections, infectious enteritis, cystitis, and prostatitis. Prulifloxacin is distributed in Italy, by Angelini ACRAF SpA, and in Japan by Meiji-Seika Kaisha Co., Ltd. Optimer acquired exclusive rights from Nippon Shinyaku in 2004 to develop and commercialize OPT-99 in the USA.

According to Michael N. Chang, Ph.D., President and CEO of Optimer Pharmaceuticals, "OPT-99 is a unique and safe compound and it is the first pro-drug in this class. We are very excited about the market potential of this drug."

Optimer Pharmaceuticals, Inc., an emerging biopharmaceutical company based in San Diego, CA, is focused on the discovery and global commercialization of anti-infective products for the treatment of serious infections. Optimer's other antibiotic candidate, OPT-80/PAR-101, targeted for the treatment of CDAD, is entering Phase 2b/3 trials this year. The Company also specializes in using its proprietary synthetic glycol-chemistry technology for drug discovery.

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to Optimer's plans to pursue clinical development of product candidates and the timing thereof and the potential efficacy of product candidates. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "plans,""intends,""expects" and similar expressions are intended to identify these forward-looking statements. There are a number of important factors that could cause Optimer's results to differ materially from those indicated by these forward-looking statements, including risks associated with the timing and success of pre-clinical studies and clinical trials.

Source: Business Wire

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