Receive our newsletter – data, insights and analysis delivered to you
  1. News
January 9, 2017

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.

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.

Content from our partners
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide
Why Asia-Pacific is the next frontier for decentralized clinical trials

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU