Alnylam Presents Positive Data on PCSK9 Synthesis Inhibitor

Alnylam Pharmaceuticals, Inc. ALNY and The Medicines Company MDCO presented initial data from their ongoing phase I study on ALN-PCSsc for the treatment of hypercholesterolemia. ALN-PCSsc, an RNAi therapeutic, targets PCSK9.

Initial data showed that a single subcutaneous dose administration of ALN-PCSsc led to dose-dependent, durable and statistically significant reductions of low-density lipoprotein cholesterol (LDL-C) of up to 83% with an up to 64 ± 5% mean maximum reduction.

These data were presented at the European Society of Cardiology (ESC). The candidate was found to achieve up to an 83% lowering of LDL-C level. Importantly, the reduction was maintained for more than 140 days which supports the potential to pursue a once- quarterly and maybe a bi-annual subcutaneous dosing regimen.

With the presentation of the initial data from phase I, the responsibility to develop the candidate shifts from Alnylam to the Medicines Company, which will evaluate the candidate under the ORION development program. A phase II study on ALN-PCSsc is expected to begin by year-end while a phase III study is expected to begin by the end of 2017. The program will include a study comparing ALN-PCSsc to anti- PCSK9 MAbs.

We note that last week, Amgen Inc.‘s AMGN PCSK9 inhibitor, Repatha, was approved by the FDA as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C. Repatha is expected to be available in the market from this week.

Alnylam carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector include Gilead Sciences Inc. GILD, sporting a Zacks Rank #1 (Strong Buy).

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