Early Phase 3 Data Suggest Sanofi, Regeneron Pharmaceuticals, Inc. Drug May Halve Heart Risk
Published: Sep 03, 2014
September 2, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
On Aug. 31, Sanofi and Regeneron Pharmaceuticals announced positive results from four Phase 3 ODYSSEY trials of alirocumab in people living with hypercholesterolemia.
The ongoing ODYSEEY long-term trial is more than 2,341 patients participating in the double-blind study. The trial is designed to determine how safe and effective 150 milligrams of alirocumab can be every two weeks, in comparison to a placebo. Individuals participating in the study have hypercholesterolemia and a high cardiovascular risk.
Researchers discovered at the primary efficacy endpoint of the trial, at 24 weeks, there was a 61 percent reduction from baseline LDL-C levels in individuals who received alirocumab. This is compared to a 1 percent increase in patients who were administered a placebo.
At the 52-week mark, there was a 57 percent drop from baseline LDL-C levels in people who were given alirocumab. This was in comparison to a 4 percent increase in patients who were given a placebo.
By the end of the analysis, approximately 81 percent of alirocumab patients achieved their LDL-C goal, compared to just 9 percent of people who received the placebo.
In three additional trials (ODYSSEY COMBO II, FH I and FH II), patients received 75mg of alirocumab every two weeks. These trials also showed positive results.
"As physicians, we often start patients on a lower dose of a medication and only increase it if needed. In these trials, the majority of patients who were started at a 75 mg dose of alirocumab, were able to achieve their target LDL-C goals while remaining on their initial dose," said Christopher Cannon M.D., Professor of Medicine, Harvard Medical School.
The four ODYSSEY trails that were revealed in this most recent update incorporated more than 5,000 patients in double-blind trials for a maximum of 104 weeks. The ODYSSEY clinical trial program continues today.
France-based Sanofi is dedicated to discovering, developing and distributing therapeutic solutions to patients in a wide range of areas. The company focuses on diabetes solutions, vaccines and consumer healthcare in emerging markets.
Regeneron Pharmaceuticals, based in New York, develops and manufactures biologic medicine for the treatment of serious medical conditions. The company is dedicated to improving the lives of those with eye diseases, colorectal cancer, and hypercholesterolemia.