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ODYSSEY trials: Alirocumab met primary efficacy endpoint for LDL reduction
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Regeneron Pharmaceuticals and Sanofi announced favorable results from nine phase 3 trials of the investigational PCSK9 inhibitor alirocumab in patients with hypercholesterolemia.
The nine trials, all part of the ODYSSEY program, achieved the primary endpoint of greater percentage reduction in LDL cholesterol after 24 weeks of treatment with alirocumab as compared with placebo or an active comparator. These results follow similar favorable outcomes from the ODYSSEY MONO trial, according to a press release.
The trials, which assessed more than 5,000 patients for 24 to 104 weeks, included:
- ODYSSEY FH I, FH II and HIGH FH, which evaluated patients with heterozygous familial hypercholesterolemia.
- ODYSSEY COMBO I, COMBO II, OPTIONS I, OPTIONS II and LONG TERM, which evaluated patients with high or very high CV risk.
- ODYSSEY ALTERNATIVE, which evaluated patients at moderate to very high CV risk who had a history of statin intolerance.
Excluding some participants in the ODYSSEY ALTERNATIVE trial, all patients received alirocumab along with standard-of-care lipid-lowering therapy.
Two dosing regimens were evaluated: 150 mg every 2 weeks or an initial dose of 75 mg every 2 weeks that could increase to 150 mg in order to achieve LDL targets. Both doses were administered via self-injection, according to the release. George D. Yancopoulos, MD, PhD, chief scientific officer of Regenreon and president of Regeneron Laboratories, said that, among trials that incorporated the two regimens, most patients were able to achieve the LDL targets without increasing from a 75-mg dose.
Treatment with alirocumab was well-tolerated in all nine trials, according to the release. Commonly reported adverse events included upper respiratory tract infection and nasopharyngitis, which occurred at a similar rate in the treatment groups. Reactions at the injection site were more common among treated patients compared with placebo recipients.
“The robust data from these studies … is the basis of our global regulatory submissions, which we expect in the United States and European Union by year end,” Elias Zerhouni, MD, president of global research and development at Sanofi, stated in the release. “We look forward to potentially providing a new treatment option for patients who may need a more aggressive cholesterol-lowering treatment on top of standard of care.”
The ongoing ODYSSEY program also includes CHOICE I and CHOICE II, which will assess monthly alirocumab, and OUTCOMES, which will evaluate the CV benefit of alirocumab in a cohort of 18,000 patients. Results for the primary endpoints of these studies are anticipated in 2015 or later.