A San Diego company developing an antibiotic for traveler's diarrhea said results from a late-stage clinical trial show that its product is faster and works on a broader range of gut-wrenching bacteria than those already on the market.
The trial showed that one dose of Optimer Pharmaceuticals' once-daily Prulifloxacin started curing traveler's diarrhea within 24 hours, the company reported yesterday.
Those results were expected, at least by Optimer, which in 2004 bought the U.S. development rights to the drug from Japanese pharmaceutical company Nippon Chinyako, Chief Executive Michael Chang said. The drug is already marketed overseas to travelers suffering from an intestinal bacterium that leaves them running for the bathroom.
Optimer hopes this clinical trial and another under way will help get Prulifloxacin on the U.S. market by 2010.
Shares of Optimer rose 52 cents, or 6.6 percent, to close yesterday at $8.40.
Taken as a pill once daily for three days, Prulifloxacin was generally well-tolerated and had a safety profile similar to the placebo, Chang said. The trial was conducted in Peru and Mexico with business executives and medical students enrolled in Spanish-immersion programs, Chang said.
It was effective on several pathogens that cause the dreaded problem. A second clinical trial in India, Guatemala and other parts of Mexico that will conclude this fall is expected to show whether the drug is effective on even more pathogens, Chang said.
That could be good news for travelers, because it has the potential to be closer to a one-pill-fits-all treatment. Therapies now on the market are more selective in the pathogens they treat, and require several doses a day over a longer course of treatment, Chang said.
He said the company hopes to file an application early next year asking the Food and Drug Administration to approve Prulifloxacin for market. The company envisions offering it in a three-pill prescription pack.
The company said that if the drug is approved, it would be a good therapy for outbreaks of salmonella and E. coli.
Terri Somers: (619) 293-2028; terri.somers@uniontrib.com
