Medicines Company reports positive interim results from ORION-1 Phase ll study of Inclisiran


US-based biopharmaceutical firm Medicines Company has reported positive results from an interim analysis of ongoing ORION-1 Phase ll study of its investigational PCSK9 synthesis inhibitor, Inclisiran, to treat hypercholesterolemia.

The results were found at day 180 from baseline of the ORION-1 study, a placebo-controlled, double-blind, randomised Phase ll study of single or multiple subcutaneous injections of Inclisiran.

A total of 501 patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents such as diabetes and familial hypercholesterolemia, as well as elevated LDL-C despite maximum tolerated doses of LDL-C lowering therapies were enrolled in the study.

Results of the interim analysis have continued to show a significant and durable LDL-C reduction among the patients, reaffirming the potential for a highly differentiated, low-volume dosing regimen of two or three injections per year.

Inclisiran was also found to be well tolerated with no material safety issues, including investigational drug-related elevation of liver enzymes, neuropathy or change in renal function reported during the trial.

"Our initiation of the ORION-2 study and enrolment of ORION-1 patients into the ORION-3 extension study … demonstrate our strong commitment to these patients."

Additionally, injection site reactions with Inclisiran were observed as infrequent, transient and mild or moderate phenomena.

Medicines Company CEO Clive Meanwell said: “We continue to focus our resources on thoughtfully and aggressively advancing Inclisiran into Phase lll development to ensure that this promising new treatment option is made broadly available to the millions of at-risk, often non-adherent patients worldwide who continue to struggle with high cholesterol using available therapies.

“Our initiation of the ORION-2 study and enrolment of ORION-1 patients into the ORION-3 extension study, both of which we announced today, demonstrate our strong commitment to these patients.”

The company has also initiated the new ORION-2 study of Inclisiran to treat patients with Homozygous Familial Hypercholesterolemia (HoFH).

Furthermore, ORION-3, a Phase ll, open-label extension study with an active comparator (evolocumab) for patients completing the ongoing ORION-1 study has also been started.