The Medicines Co. Offers Update On Dyslipidemia Programs

The Medicines Company (NASDAQ:MDCO) came up with important announcements related to its pipeline. The company provided an update on its dyslipidemia programs – MDCO-216 (which contains APoA-1 Milano) and PCSK9si (PCSK9 synthesis inhibitor).

MDCO-216 Misses Early Termination Criteria

The Medicines Co. reported that a planned, interim analysis of the first 40 randomized patients, who completed treatment in the MILANO-PILOT study on MDCO-216, has been reviewed by an Independent Data Monitoring Committee (IDM Committee). Based on the protocol and pre-defined criteria, the IDM Committee recommended the continuation of the MILANO-PILOT study.

The 40-patient data from the MILANO-PILOT study failed to meet the pre-defined, upper statistical boundary efficacy threshold for early termination. Since only a limited number of patients were involved in the first interim analysis, summary data received by the company from the IDM Committee are inconclusive at this moment.

We note that MILANO-PILOT is a proof-of-concept, double-blind, placebo-controlled, randomized study that aims to improve cardiovascular outcomes by reducing plaque burden in patients with atherosclerotic disease. The Medicines Co. has completed enrollment of the planned 120 patients. Data from the study will be presented at the American Heart Association (AHA) Scientific Sessions in Nov 2016.

PCSK9 Synthesis Inhibitor Study Fully Enrolled

Concurrently, The Medicines Co. announced that it has completed enrollment in the ORION-1 phase II study on PCSKsi (also known as ALN-PCSsc) ahead of schedule. An interim analysis with a day 90 follow-up for all patients will be conducted and presented at the AHA Scientific Sessions this November. The company anticipates the day 180 follow-up for all patients to be completed, analyzed and presented by the year end.

ORION-1 is a placebo-controlled, double-blind, randomized study that is being conducted on single or multiple subcutaneous injections of PCSK9si in patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (like diabetes and familial hypercholesterolemia) and elevated LDL-C despite maximum tolerated doses of LDL-C lowering therapies.

The Medicines Co. believes that PCSK9si is a first-in-class experimental treatment that acts by turning off PCSK9 synthesis in the liver in contrast to anti-PCSK9 monoclonal antibodies that bind to PCSK9 in blood. Currently, there are two PCSK9 inhibitors available in the market – Amgen Inc.’s (NASDAQ:AMGN) Repatha and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) /Sanofi’s (NYSE:SNY) Praluent.

The Medicines Co. currently carries a Zacks Rank #3 (Hold). Regeneron is a better-ranked stock in the healthcare sector, with a Zacks Rank #2 (Buy).

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