PARIS (dpa-AFX) - Sanofi (SNY) and Regeneron Pharmaceuticals Inc. (REGN) announced detailed positive results from four Phase 3 ODYSSEY trials of alirocumab in people with hypercholesterolemia. Results from the four ongoing trials, all of which met their primary efficacy endpoint, will be presented today at a Hot Line session at the ESC Congress 2014 in Barcelona, Spain.
Alirocumab is an investigational monoclonal antibody targeting PCSK9 or proprotein convertase subtilisin/kexin type 9.
On the primary efficacy endpoint, Alirocumabs showed a 62 percent reduction in LDL-C compared to placebo at 24 weeks on top of maximally-tolerated lipid-lowering therapy in ODYSSEY LONG TERM trial.
The company will also present ODYSSEY COMBO II, FH I and FH II trials today. Alirocumab-treated patients receive an initial dose of alirocumab 75 mg every two weeks in these three trials, increasing to 150 mg if needed to reach pre-specified LDL-C levels. The 75 mg and 150 mg alirocumab doses were delivered as a single, self-administered 1 milliliter injection.
At 24 weeks, there was a 51 percent reduction from baseline in LDL-C levels in the alirocumab group compared to a 21 percent reduction in the ezetimibe group in ODYSSEY COMBO II trial.
In the ODYSSEY FH I and FH II trials, on the primary endpoint, at 24 weeks, there was a 49 percent reduction from baseline in LDL-C levels in both FH I and FH II alirocumab groups compared to an increase of 9 percent in FH I and 3 percent in FH II in the placebo groups.
Sanofi and Regeneron expect alirocumab regulatory submissions in the U.S. and EU by the end of 2014. The companies plan to use a Priority Review Voucher in the U.S. to obtain priority review status for the alirocumab regulatory submission.
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