The Medicines Co. recently released update information regarding its ORION-1 clinical trial, which revolves around PCSK9si, the company’s investigational PCSK9 synthesis inhibitor.
The Phase II ORION-1 trial is being conducted on patients who have atherosclerotic cardiovascular disease (ASCVD) or those who could be at risk as well as increased LDL-C even after treatments designed to lower LDL-C. The trial administers various doses of PCSK9si and then assesses if a possible quarterly or bi-annual regimen could be tolerated by the patient.
“These impressive, emerging safety data support our view that PCSK9si has a highly-competitive profile as compared with anti-PCSK antibodies and we look forward to presenting results from the ORION-1 study at the AHA meeting on November 15, 2016,” The Medicines Co. CEO Dr. Clive Meanwell said. “In particular, we believe that PCSK9si has the unique potential to provide new, innovative solutions to patients, payers and providers through a quarterly or, potentially, bi-annual, low-volume subcutaneous dosing regime and by linking the LDL-C monitoring cycle with administration of therapy.”
The ORION-1 trial’s primary goal is the LDL-C change in percentage at 180 days compared to the baseline. The trial is being conducted on 501 patients, surpassing its target of 480.