Amgen (AMGN) recently presented positive data on its hypercholesterolemia candidate, AMG145. Results were presented at the American College of Cardiology Scientific Session from a phase Ib study that was conducted in high cholesterol patients taking statins.
Results in Detail
AMG 145, a fully human monoclonal antibody, is a PCSK9 inhibitor. The phase Ib study (n=51) was conducted to evaluate the safety, efficacy and tolerability of AMG145 compared to placebo. Results showed that patients on low to moderate doses of statin experienced a mean reduction in LDL-C (bad cholesterol) levels of up to 75% (at week 6) when administered AMG145 every two weeks.
Patients on low-to-moderate doses of statin experienced a mean reduction in LDL-C (bad cholesterol) levels of up to 66% (at week 8) when administered AMG145 every four weeks. Meanwhile, patients on high doses of statin experienced a mean reduction in LDL-C (bad cholesterol) levels of up to 63% (at week 6) when administered AMG145 every two weeks.
Amgen said that the magnitude and duration of effect depended on the dose, with PCSK9 being undetectable at higher doses.
Phase II Studies Ongoing
AMG145 is currently in a phase II program consisting of six studies which will involve about 1,900 patients. The program will not only evaluate AMG145 plus statins in patients with or at risk for cardiovascular disease, it will also be studied in patients who cannot tolerate statins. Besides this, AMG145 will be evaluated as a stand-alone treatment in patients with low cardiovascular risk, and in patients with heterozygous familial hypercholesterolemia. Amgen said that results from these studies should be out later this year.
Intense Competition
Although statins (the current standard of treatment) are effective, many patients have problems achieving their cholesterol goals. Moreover, several patients are unable to tolerate statin therapy. In such a scenario, the successful development of PCSK9 inhibitors would be a major breakthrough in the area of cholesterol management. Besides Amgen, several other companies are working on developing PCSK9 inhibitors for cholesterol management.
Companies working on PCSK9 inhibitors include Sanofi/Regeneron (SNY/REGN) and Alnylam (ALNY).
Outperform on Amgen
We currently have an Outperform recommendation on Amgen, which carries a Zacks #2 Rank (short-term “Buy” rating). We are bullish on Prolia/Xgeva and we expect Amgen to utilize its cash towards share buybacks and acquisitions or deals that will help boost its pipeline and drive long-term growth.
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