Gunning to catch up with the leading PCSK9 inhibitor in the pipeline, Amgen on Sunday posted an impressive slate of Phase Ib data for AMG 145, a blockbuster hopeful in a pack of drug candidates that promises to dramatically lower LDL, or "bad" cholesterol.
For the cohort taking the highest dosage, AMG 145 reduced LDL levels by a mean average of almost 81% on top of the statins they were taking, says Clapton Dias, an Amgen scientist who's working on the development program. Patients on low to moderate levels of statins taking AMG 145 every two weeks experienced a mean reduction of LDL of 75% at week six compared to placebo. Patients taking a high dose of statins registered a 63% reduction in LDL at week six. And Reuters focused on a 66% reduction in LDL among patients taking the treatment monthly.
Amgen is one step behind REGN727/SAR236553, another antibody program which has also produced impressive results at lowering LDL. Sanofi and Regeneron are delivering Phase II results this morning as they push ahead, trying to demonstrate that they can stay in the lead in the race to the FDA. The winner gets first crack at a potential market worth billions. And Amgen is acutely aware of the stakes.
"Phase II is going well, with results available later this year. We don't think we're far behind," Dias told FierceBiotech over the weekend, as Amgen made its presentation to the American College of Cardiology. The scientist adds that he views AMG 145 as a "breakthrough" treatment with novel pharmacokinetics and a clean safety profile. "I think Amgen is doing everything it can to accelerate AMG 145."
There are almost 1,900 subjects enrolled in mid-stage studies, says Dias, and Amgen is looking at this "more broadly," with a number of different population groups, from treatment refractory on to at-risk patients, as a standalone treatment and in combination, with a bi-weekly and monthly dosing schedule.
The antibody is designed to inhibit PCSK9, a protein that essentially prevents liver cells from cleaning up LDL. People with naturally low levels of PCSK9 demonstrate low levels of LDL and risk for cardiovascular disease. And in a world where boosting good cholesterol and cutting back bad cholesterol offers major health benefits, the biopharma industry has mounted a slate of some of the most ambitious studies in the business.
Amgen, Sanofi and Regeneron aren't the only companies in this race. Alnylam, an RNA company, has an early-stage program aimed at inhibiting PCSK9, while Pfizer, Merck and Bristol-Myers Squibb, in partnership with Isis, have all referenced programs of their own. Gaining an approval won't be easy. Any treatment ultimately aimed at a major market like this will have to deliver a large body of clean safety data.