Results from two Phase II studies, released at the American Heart Association’s Los Angeles conference, suggest Amgen’s experimental cholesterol treatment AMG-145 may have legs. The studies, which were published separately by the Journal of the American Medical Association and Circulation, indicate the treatment could help drive down LDL levels, also known as “bad” cholesterol levels, among two hard-to-treat groups: patients who cannot tolerate statins and patients whose cholesterol is high and can’t be sufficiently budged using only statins.
JAMA‘s study focused on patients who are driven away from statins because of side effects. The researchers estimated that about 10% to 20% of patients, or 20 million people, can’t use the therapy which helps drive down bad cholesterol levels and elevated pharmaceutical revenue streams prior to the patent cliff that has turned many of them generic. The most common side effect among this group is muscle pain, and ezetimibe (aka Merck’s Zetia), which prevents cholesterol absorption, is the most commonly used treatment for patients who cannot tolerate statins. The researchers noted that this therapy tends to reduce bad cholesterol levels by 18%, “which alone is unlikely to achieve LDL-C goals.”
Amgen’s proposed treatment, which belongs to the drug class known as PCSK9 inhibitors, works by binding to the LDL receptors, and researchers found that levels dropped between 41% and 63% “without significant muscle-related side effects.” They also noted that these numbers are on par with “the most efficacious statins.”
Phase II research appearing in Circulation also showed LDL levels fall. The study’s authors estimate that about 12 million patients with genetically-linked high cholesterol fall into this category. They also noted that this population is at a high risk for premature cardiac death. Phase I trials among this same patient group showed LDL levels dropped about 81% versus placebo. In this round, researchers saw LDL levels drop between 66% and 72% during the first two weeks, compared to the 3% falls vs.placebo. They also found levels continued to drop during the four-, eight- and 12-week check-ins.
Amgen was slated to release information from additional studies at the conference this afternoon.