* Amgen anti-PCSK9 drug slashes LDL in healthy volunteers
* Patients followed for 85 to 113 days after one injection
* Data come on heels of favorable Regeneron studies
By Ransdell Pierson
Nov 14 A potentially powerful new approach to
lower cholesterol by blocking a protein called PCSK9 gained
ground, as a new drug from Amgen Inc cut levels of
"bad" LDL cholesterol by almost two-thirds in a small study.
The world's largest biotechnology company on Monday
presented data from the early stage trial that showed the
highest dose of its treatment AMG145 cut LDL levels 64 percent
in healthy volunteers, compared with a placebo injection.
The study, whose results were presented at the annual
scientific meeting of the American Heart Association in
Orlando, involved 54 men and two women -- 18 to 45 years old --
who were healthy and not taking other medications.
They received a single injection that contained one of five
doses of AMG145, or a placebo, and their cholesterol was
measured frequently for 85 to 113 days.
"The more PCSK9 was lowered, the more bad cholesterol
levels went down," said Clapton Dias, a senior Amgen research
executive who led the study. "With higher doses, bad
cholesterol stayed lower for a longer period."
Amgen said it is now conducting a similar study among
adults who are already taking standard treatments called
statins to control their cholesterol.
The California-based company is among a growing number of
drugmakers that are racing to develop medicines that block
U.S. biotechnology company Regeneron and its
French pharmaceutical partner Sanofi are way out
front, with plans to soon begin late-stage studies of their
injectable product REGN727.
The companies last week said their drug, when given at
varying doses in combination with statins, further reduced LDL
levels 30 percent to more than 65 percent. The patients have
familial hypercholesterolemia, an inherited condition
associated with very high LDL levels.
Other companies testing anti-PCSK9 medicines include Pfizer , Merck & Co , Alnylam Pharmaceuticals
and a partnership between Bristol-Myers Squibb and Isis
The products, if approved, are expected to be used
alongside statins, such as Pfizer's Lipitor and AstraZeneca's Crestor, for patients who do not achieve
cholesterol-lowering goals with statins alone.
They would also be used on their own for a much smaller
group who cannot tolerate statins -- oral drugs with global
annual sales of $20 billion that inhibit the liver's production
of LDL cholesterol.