Amgen Reports Positive Top-Line Results From Phase3 MENDEL-2 Trial Of Evolocumab

(RTTNews) - Amgen (AMGN) announced Tuesday that the Phase 3 MENDEL-2 (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2) trial with evolocumab met its co-primary endpoints: the percent reduction from baseline in low-density lipoprotein cholesterol or LDL-C at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12.

The mean percent reductions in LDL-C, or "bad" cholesterol, compared to placebo and ezetimibe were consistent with results observed in the MENDEL Phase 2 study.

Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.

Amgen noted that the MENDEL-2 trial evaluated safety, tolerability and efficacy of evolocumab in 614 patients with high cholesterol (LDL-C = 100 mg/dL and < 190 mg/dL) who were not receiving lipid-lowering therapy. Patients were randomized to one of six treatment groups to compare two dosing regimens of evolocumab (140 mg every two weeks or 420 mg monthly) with placebo and ezetimibe (10 mg daily).

Safety was balanced across treatment groups. The most common (>2 percent in evolocumab combined group) adverse events (AEs) were headache, diarrhea, nausea and urinary tract infection.

In a separate press release, Atara Biotherapeutics, Inc.,announced that it has secured $38.5 million in initial closings under its Series B financing. In this round, investors Amgen Ventures), Celgene Corporation (CELG), and EcoR1 Capital, joined existing investors Alexandria Venture Investments, DAG Ventures, Domain Associates, and Kleiner Perkins Caufield & Byers.

Atara said that it will use proceeds to accelerate the clinical development of its two lead programs, PINTA 745 and STM 434, which are expected to generate new clinical data within the next 18 months.

In conjunction with the financing, Atara announced that it has appointed Joel Marcus, chairman, chief executive officer, and founder of Alexandria Real Estate Equities, Inc. (ARE) / Alexandria Venture Investments to the board of directors of the Atara family of companies.

The financing relates to three biotechnology entities - Nina Biotherapeutics, Inc., Pinta Biotherapeutics, Inc., and Santa Maria Biotherapeutics, Inc. - in the Atara family of companies. Atara's unique structure was designed to help enable investors to preserve optionality and maximize potential value creation. Atara has raised more than $58 million to date for this family of companies.