Sanofi & Regeneron Trumpet Phase II Results of Alirocumab in Japan

Sanofi and Regeneron’s investigational monoclonal antibody alirocumab met its primary endpoint in a Japanese Phase II study, the drugmakers announced Tuesday.

The placebo-controlled, multicenter study randomized 100 patients with low-density lipoprotein cholesterol levels of 100 mg/dL or more who were already on lipid-modifying therapy into dosing arms of 150 mg, 75 mg or 50 mg. All of the patients also received statins.

By week 12 of the study, patients injected with 50 mg of alirocumab experienced a 55 percent reduction in LDL-C, or bad cholesterol, while patients at the 75 mg and 150 mg dose levels had 62 percent and 72 percent lower LDL-C, respectively. By contrast, patients in the placebo group saw a 3 percent decline in LDL-C over the period.

Jay Edelberg, head of the PCSK9 Development and Launch Unit at Sanofi, said the trial results not only show that alirocumab significantly reduces LDL-C in this patient population but also that the drug is likely to be effective in a range of doses.

The ODYSSEY program of 17 Phase III trials evaluating alirocumab as a monotherapy and in combination with statins is ongoing and encompasses 23,500 patients from six continents, Regeneron’s Sandra Sexton told Drug Daily Bulletin. The company expects to file for regulatory approval in 2015.

Alirocumab is one of a class of drugs known as PCSK9 inhibitors. PCSK9 determines LDL-C levels by binding to LDL receptors and degrading them, causing liver cells to remove less of the cholesterol from the blood.

PCSK9 inhibitors are a hot item in the field of cholesterol control. Amgen announced in November that its evolocumab had removed 52 percent of LDL-C in patients in a Phase II study. Roche, Alnylam, Bristol-Myers Squibb, Pfizer and Merck all have PCKS9 inhibitors in various phases of development.

In recent guidance, the FDA said sponsors of PCSK9 inhibitors would only need to demonstrate a drug’s effectiveness at lowering LDL-C, blood pressure and inflammation, not whether it reduces heart attack or stroke. — Lena Freund

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