Regeneron, Sanofi Show Off Positive Cholesterol Drug Data
Published: Jan 12, 2015
January 9, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
Regeneron Pharmaceuticals, Inc. , and Sanofi announced today that their two ODYSSEY trials, which looked at alirocumab for the treatment of cholesterol, met their primary endpoints. The ODYSSEY trials were Phase III trials designed to look at how alirocumab impacted patients when administered every four weeks.
The trials were in comparison to the reduction in low-density lipoprotein cholesterol at 24 weeks with alirocumab versus the placebo. Patients who were living with hypercholesterolemia participated in the studies.
"In the new monthly dosing trials, ODYSSEY CHOICE I and CHOICE II, the mean percent reduction in LDL-C from baseline was consistent with that seen in previous Phase III trials evaluating alirocumab every other week dosing," said Bill Sasiela, vice president of program direction in cardiovascular and metabolic studies at Regeneron. "These results continue to validate our clinical development approach, which is designed to investigate various alirocumab doses and intervals to address patients' lipid-lowering needs."
ODYSSEY CHOICE I looked at the efficacy and safety of alirocumab in 803 patients at moderate to high cardiovascular risk, while ODYSSEY CHOICE II examined it in patients with the same risk and a history of intolerance to two or more statins.
"Despite current lipid-lowering therapies, many patients at high CV risk struggle to reach optimal LDL-C levels," said Jay Edelberg, head of the PCSK9 Development & Launch Unit at Sanofi. "The ODYSSEY clinical trial program has provided key insights and allowed us to investigate alirocumab administered every four weeks in different patient populations, including those who cannot get control of their high LDL-C because of difficulty tolerating statin therapy."
The most common adverse effects of the drug were headache, upper respiratory tract infection and nausea.
Early Promise for Alirocumab
In October 2013, Sanofi and Regeneron Pharmaceuticals released news that showed early promise for the drug after its first Phase III study. The ODYSSEY MONO trial met its primary endpoint and showed that it could reduce the mean low-density lipoprotein cholesterol in patients after 24 weeks.
"We are excited with the findings from the first Phase 3 trial with alirocumab. While the majority of our clinical program is investigating alirocumab in combination with lipid-lowering therapies, these monotherapy results are encouraging,” Edelberg said at the time of the announcement. "As in this trial, several of our Phase III studies will utilize an up-titration approach, the aim of which is to bring patients to goal with the lowest effective dose of anti-PCSK9 antibody. We look forward to results from the remaining Phase 3 trials, which are investigating alirocumab in a variety of patient populations, combinations with different background therapies, and dosing regimens."