San Diego-based Optimer Pharmaceuticals has nailed the second big trial designed to prove it has a new antibiotic for a deadly infection people can get in hospitals.
Optimer (NASDAQ: OPTR) said today that it reached its main goal of showing its experimental antibiotic, fidaxomicin, was roughly equivalent to the gold standard vancomycin drug when attempting to cure patients infected with “C.difficile” bacteria. The Optimer drug was about twice as good as vancomycin at preventing dangerous recurrences.
The findings, from a trial of 535 patients in North America and Europe, confirm what Optimer found from a previous trial of 600 patients, which was reported back in November 2008. Now that both pivotal studies are complete, Optimer plans to ship off a new drug application to the FDA by the second half of this year. If approved, fidaxomicin would be Optimer’s first marketed product, and it could represent the first new effective treatment for “C.diff” in decades. This particularly nasty bug causes severe diarrhea, the kind that can lead to severe dehydration, inflammation of the colon, hospitalization, and death.
Hospitals aren’t exactly too keen on reporting how often their patients suffer this infection, but about 30 to 40 cases were reported per 100,000 people discharged from these institutions in 2001, and that figure has climbed to about 100 cases per 100,000 discharges in 2005, according to data from the Centers for Disease Control and Prevention.
“The growing incidence of C.difficile in hospitals, long-term care facilities, and in the community, which we believe is caused in part by the use of broad-spectrum antibiotics and an aging population, create a need for new therapies,” said Sherwood Gorbach, Optimer’s chief medical officer, in a statement.
The latest trial found that 91.7 percent of patients on the Optimer drug had a clinical cure, compared with 90.6 percent on standard vancomycin. About 12.8 percent of patients on the Optimer drug had a recurrence, compared with 25.3 percent in the control group. The new drug was considered well-tolerated, Optimer said.
Shares of Optimer climbed 20 percent in after-hours trading following the announcement. Optimer plans to discuss the results in more detail with investors on a conference call at 5 pm Eastern/2 pm Pacific time.
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