PCSK9 Race Heats Up as Amgen Candidate Enters Phase III

Positive results from the first long-term trial of evolocumab, Amgen’s next-generation heart drug, are heating up the race to develop the emerging class of drugs known as PCSK9 inhibitors.

The results from the Phase II extension trial known as OSLER reflect the sponsor’s first full set of long-term data (52 weeks) and come as evolocumab, or AMG 145, pushes into Phase III. Top-line results from four of the 13 trials planned as part of Amgen’s Phase III PROFICIO program are expected to be released early next year, spokeswoman Ashleigh Koss said Nov. 20.

In OSLER, Amgen’s candidate, combined with an unnamed standard of care (SOC), removed low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood in patients with high cholesterol at a rate of 52 percent, the drugmaker said. When compared to SOC, evolocumab did not markedly increase adverse events (81.4 percent versus 73.1 percent in SOC).

In earlier Phase II trials of shorter duration, evolocumab reduced LDL-C by up to 65 percent and was well tolerated by hundreds of enrolled hypercholesterolemic patients, according to Amgen.

The Amgen candidate is one of a number of PCSK9 inhibitors currently under development. Evolocumab catches Amgen up with Roche, Sanofi and Regeneron and their late-stage PCSK9 inhibitors. Pfizer, Bristol-Myers Squibb, Merck and Alnylam Pharmaceuticals have candidates in various stages of early development.

The drugmakers got a break from the FDA two weeks ago when it clarified its expectations for developers of PCSK9 inhibitors. The agency’s regulatory decisions will be based on “the compound’s effects on the entire lipoprotein lipid panel, particularly LDL-cholesterol, its effects on other markers of potential cardiovascular risk … and blood pressure, and any evidence of off-target toxicity,” spokeswoman Lisa Kubaska said.

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