Optimer Pharmaceuticals has good news today for people with a serious bacterial infection. The San Diego-based biotech company (NASDAQ: [[ticker:OPTR]]) said its experimental drug was slightly better at curing patients than the standard antibiotic for C.Difficile bacterial infection, and was significantly better at preventing the nasty bug from coming back after treatment. Shares of the company doubled to $9 in after-hours trading today following the news.
About 92.1 percent of patients on Optimer’s drug, OPT-80, were considered clinically cured compared with 89.8 percent who took standard vancomycin in a trial of 629 adults, the company said today after markets closed. About 13 percent of patients on the Optimer drug had a relapse after their first round of treatment, compared with 24 percent who had a recurrence after getting standard treatment. The Optimer drug, taken as a twice-daily pill for a 10-day course, was well-tolerated, the company said. The treatment is designed, unlike some broad-sweeping antibiotics like metronidazole and vancomycin, to kill the pathogen while mostly sparing the normal, healthy bacteria we all have in the gut.
The results are a coup for the company, and for researchers that haven’t found anything new to combat “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. It is a thorn in the side of hospitals and nursing homes, that is becoming increasingly more common, according to Stuart Johnson, a Loyola University researcher I interviewed last month. About 30 to 40 cases were reported per 100,000 people discharged from hospitals 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. These cases are so desperate that some doctors are experimenting with stool transplants given via enema in order to restore normal bacteria in the colon that can help ward off the infection, Johnson says.
Optimer still has to show its drug works in another pivotal trial of more than 600 patients, but the first trial is clearly an encouraging sign that the company could be on its way to filing an application for clearance to market the drug from the FDA. Optimer’s drug is the only “C. Diff” candidate in the final stage of clinical trials, so physicians have been eagerly anticipating these results, Johnson said last month. Reducing the rate of recurrence is important, because those patients are usually the toughest to treat, Johnson said.
“We are happy with the results,” said Optimer CEO Michael Chang, in a conference call with analysts. He added that the company expects to report findings from its second clinical trial in the second half of 2009.
