Biotechnology giant Amgen has presented a run of strong clinical data for evolocumab at the American College of Cardiology meeting, backing its bid to get the first PCSK9 inhibitor to market for the reduction of cholesterol.
Among the results were those from two Phase III pivotal studies showing that the drug - an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood - induced a statistically significant cut in low-density lipoprotein cholesterol (LDL-C).
Data from the GAUSS-2 study showed a reduction of 37%-39% compared to ezetimibe in patients with high cholesterol unable to tolerate statins, while findings from the LAPLACE-2 trial showed cuts of 55%-76% versus placebo when used in combination with statin therapy.
And things were also looking good on the safety side, with the most common adverse events (_5% in the combined evolocumab group) in the GAUSS-2 study being headache, myalgia, pain in extremity and muscle spasms.
In the LAPLACE-2 study, no AEs occurred in _2% of the evolocumab combined group, but the most common were back pain, arthralgia, headache, muscle spasms and pain in extremity.
Overall, the company presented data from five Phase III pivotal studies spanning more than 4,000 patients, which have provided "important insights on the potential of evolocumab as a treatment for a range of patients at-risk for cardiovascular disease," said Sean Harper, executive vice president of Research and Development at Amgen,
Up to 80% of high risk patients are still not reaching their cholesterol treatment goals using statin therapy, highlighting the need for new therapies, and analysts believe that the PCSK9 inhibitors could rake in sales of around $3-$4 billion each.
The firm is hoping that their drug will be able to help patients who are on a moderate or high-intensity statin and not adequately controlled, as well as patients who cannot tolerate statins and are in need of an alternate treatment option to help lower their LDL cholesterol levels, and are "working closely with regulatory authorities on our global filing plan in hopes of bringing this new treatment option to patients with dyslipidaemia," Harper noted.