Shares of Optimer Pharmaceuticals zoomed up 20 percent after the developer announced another set of promising data from a large, late-stage study of its experimental antibiotic, fidaxomicin. And the San Diego-based developer says it is now ready to assemble an NDA that can be filed in the second half of this year.
Studying the results of a trial that enrolled 535 patients, Optimer says that the antibiotic proved twice as effective as vancomycin in preventing recurrences of infections and as effective as the antibiotic mainstay in curing patients who had been infected with "C.difficile" bacteria. The data confirm the results of a 2008 trial.
In the latest trial researchers report that the drug cured 91.7 percent of patients compared to 90.6 percent treated with vancomycin. Slightly fewer than 13 percent of patients had a recurrence, roughly half the rate of the vancomycin group.
"The robust results from our second Phase III trial of fidaxomicin confirm the results of our first Phase III trial showing that fidaxomicin has the potential to be a first-in-class drug for the treatment of Clostridium difficile infection. There are currently limited treatment options for this disease and we believe there is a need for innovative alternatives," said Michael N. Chang, Ph.D., Optimer's CEO.