12:00 AM
Sep 21, 2015
 |  BioCentury  |  Product Development

Alnylam's lipid sync

Why Alnylam, Medicines Co. think ALN-PCSsc could best anti-PCSK9s on adherence

Alnylam Pharmaceuticals Inc. and The Medicines Co. think an RNA-based approach to lowering LDL-C could help patients adhere to treatment by enabling them to receive therapy at the same time they are normally scheduled for a cholesterol check. The partners are exploring whether the treatment could be offered at laboratories or pharmacies where cholesterol is checked, and intend to collect data on adherence to satisfy payers.

Phase I data presented at the European Society of Cardiology meeting on Aug. 30 showed a single dose of ALN-PCSsc resulted in mean LDL lowering of 28-48% vs. 7% for placebo across dose cohorts after 12 weeks - the duration of study for the primary safety endpoint. The LDL lowering persisted for at least 140 days among patients who continued follow-up visits. The study enrolled healthy volunteers with elevated baseline cholesterol (LDL-C ≥100 mg/dL).

Using a least squares mean analysis, there was an LDL-C reduction of 50.1% from baseline to 12 weeks for three subjects receiving a single 300 mg dose and a 59.4% reduction for six subjects in the 300 mg once-monthly cohort.

Medicines Co. SVP of Acute Cardiovascular Care Peter Wijngaard said the mean analyses were prespecified in the statistical analysis plan, and the least squares mean analyses were exploratory. He noted a least squares mean calculation is often performed to compensate for variation in LDL assays, which can be as high as 15%.

At a Sept. 16 company presentation, Alnylam reported least squares mean analyses for all other dose groups in the trial. LDL-C reductions ranged from 26-59% for subjects receiving a single ALN-PCSsc dose, 45-59%...

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