The Medicines Company recently completed enrollment for the second phase of its study on PCSK9si, which the company is seeking to show can reduce LDL-C, or ‘bad cholesterol,’ with just a single-dose treatment every six months.
“We and our partners at Alnylam are pleased to have completed enrollment of Orion-1,” The Medicines Company Vice President and Global Medical Director David Kallend said. “We believe that PCSK9si has significant potential given its highly competitive profile as compared with anti-PCSK9 monoclonal antibodies (MAbs), a recently approved class of LDL-C lowering drugs. Indeed, in our view, the potential for management of hypercholesterolemia with two injections per year could be a transformative option for patients, physicians and payers in the treatment of atherosclerotic cardiovascular disease (ASCVD).”
The study began enrollment in January and hit its target of 480 patients sooner than expected. Patients will receive different dosages of PCSK9si to see its effect, following up from a previous study that showed significant LDL-C reductions for six months.
Duration of effectiveness could be a significant benefit to patients, as adherence to currently available treatments remains a significant problem.
“Assuming positive data from Orion-1, we are on track to initiate phase-three registration studies in early 2017,” Kallend said. “In addition, we plan on conducting studies directly comparing PCSK9si with anti-PCSK9 MAbs -- as well as studies in homozygous familial hypercholesterolemia starting this year -- to confirm the important features and potential benefits of this first-in-class investigational PCSK9 synthesis inhibitor.”