Amgen (AMGN) reported positive data from a phase III trial on its PCSK9 inhibitor, evolocumab. The trial evaluated evolocumab in 307 patients with high cholesterol who cannot tolerate statins.
The phase III GAUSS-2 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2) trial evaluated the safety, tolerability and efficacy of evolocumab. The study met its co-primary endpoints – percentage reduction from baseline of bad cholesterol (low-density lipoprotein cholesterol/LDL-C) at week 12 and the mean percentage reduction from baseline of bad cholesterol at weeks 10 and 12.
Amgen disclosed that GAUSS-2 was consistent with the phase II GAUSS trial in which evolocumab demonstrated reduction in LDL-C up to 51%. Reduction was greater (up to 63%) when evolocumab was combined with Merck & Co., Inc.’s (MRK) Zetia (ezetimibe).
Evolocumab works by inhibiting PCSK9, a protein that reduces the liver's ability to remove LDL-C from the blood.
Amgen’s phase III program for evolocumab, PROFICIO (Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations), comprises 13 phase III trials. The company has consistently reported positive phase III results on the candidate late last year.
Amgen presented positive top-line results on evolocumab from the phase III DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) study which was conducted to evaluate the long-term, 52-week safety and efficacy of evolocumab for the treatment of high cholesterol. Evolocumab met the primary endpoint of reducing bad cholesterol at week 52. Results were consistent with the 52-week analysis of the phase II OSLER (Open Label Study of Long TERm Evaluation Against LDL-C) study.
We are pleased with the positive data on evolocumab, which further boosts confidence in its efficacy. We believe evolocumab has huge market potential. However, other companies including Sanofi (SNY) are also developing PSCK9 inhibitors.
Amgen carries a Zacks Rank #3 (Hold). In the near term, we believe that investor focus will be on the release of its fourth quarter and full year 2013 results (Jan 28).
Some better-ranked stocks include Allergan (AGN), which carries a Zacks Rank #2 (Buy).