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New fully human PCSK9 antibody successful in phase 2 trial

Effects of RG7652, a Monoclonal Antibody Against PCSK9, on LDL-C, LDL-C Subfractions, and inflammatory Biomarkers in Patients at High Risk of or With Established Coronary Heart Disease

(from the Phase 2 EQUATOR Study)

Baruch A, Mosesova S, Davis JD, et al. - Am J Cardiol. 2017 Mar 1, Epub ahead of print

Background

Atherosclerosis has, additional to the role of LDL-c, a strong inflammatory component that can affect vascular health and plaque stability [1-4]. Therefore, this multicenter, randomized, double-blind, placebo-controlled phase 2 study, called EQUATOR, assessed the LDL-c lowering and the impact on inflammatory biomarkers by RG7652, a fully human PCSK9 antibody, when added to standard-of-care therapy for 6 months, in patients with a high risk for, or with established coronary heart disease (CHD). Patients were randomized to placebo (n=57 completed), RG7652 200 mg subcutaneously every 8 weeks (200 q8w, n=23 completed), 400 mg every 4 (400 q4w, n=52 completed) or 8 weeks (400 q8w, n=28 completed), 800 mg every 8 (800 q8w, n=46 completed) or 12 weeks (800 q12w, n=23 completed).

Main results

Conclusion

RG7652 significantly reduced LDL-c levels as well as ApoB and Lp(a) in high-risk CHD patients. The magnitude and duration of LDL-c-lowering were dose-dependent. On the other hand, RG7652 did not lower inflammatory markers and cytokines, suggesting that PCSK9 inhibition does not have the same effect on systemic inflammation as statins. Furthermore, no concerning AEs were experienced.

References

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Download PPT slides Find this article online at Am J Cardiol

New fully human PCSK9 antibody successful in phase 2 trial