Genzyme and Isis Pharmaceuticals have begun two new studies of mipomersen, a new lipid-lowering drug in late-stage development, and a third is currently screening patients.
The three trials will provide additional data on mipomersen in high-risk patient populations, according to the Cambridge, Mass.-based Genzyme and Carlsbad, Calif.-based Isis. The new studies, along with ongoing trials, will also increase the size of the database of patients treated with mipomersen over the next 18 months.
The companies said that third trial seeks to evaluate the safety and efficacy of mipomersen in patients with severe hypercholesterolemia who are on a maximally tolerated lipid-lowering regimen. The phase 3 study includes patients, who are not on LDL cholesterol apheresis, but who have such severely elevated LDL-C levels that they are eligible for the procedure, and will enroll up to 75 patients.
Also, the companies said they recently initiated a phase 3 trial in hypercholesterolemic patients on maximally tolerated dosages of statins who are at high risk for coronary heart disease. The study will enroll up to 180 patients. The companies also said that they have begun a new phase 2 study in high-risk, high-cholesterol patients who are intolerant to statins, which will enroll up to 30 patients.
All three new trials are double-blind, placebo-controlled studies in which patients will be randomized 2:1 to receive a 200 mg dose of mipomersen or placebo weekly for 26 weeks, with percent change in LDL-C as the primary endpoint, Isis and Genzyme said.