Isis Pharmaceuticals (ISIS) says that its experimental cholesterol drug mipomersen hit its primary endpoint in a late-stage trial, cutting levels of LDL by an average of 25 percent among patients genetically inclined to develop high cholesterol. And some patients demonstrated a reduction of 70 to 80 percent. Average LDL levels in study patients--who inherit the condition from both parents--are over 400 while guidelines call for a level under 100. The drug is given by injection once a week. Another late-stage trial examines the effect of the drug among patients who inherit the condition from one parent.
Isis' marketing partner Genzyme is expected to file for U.S. and European regulatory approval of mipomersen by the middle of 2011. Investors, though, were spooked to see that Isis plans to file for approval a year later than expected. And Isis shares plunged 15 percent.
"If it works in this condition, which is a very difficult condition to treat, it's going to work a hell of a lot better in patients with regular (high cholesterol)," says lead investigator Frederick Raal.
- check out Isis' release
- here's the story from Reuters