The Medicines Company reports on proposed release of data from ORION-11, ORION-9 and ORION-10 trials of inclisiran to treat hypercholesterolemia.

The Medicines Company reported financial results for the second quarter that ended June 30, 2019 and reported that the sequential release of topline data readouts for inclisiran upon completion of ORION-11, ORION-9 and ORION-10 is expected to start in the second half of the third quarter.

The Company plans to prepare Phase III clinical data for scientific exchange at medical congresses and in peer-reviewed journals. In line with that expectation, the Company submitted a promissory abstract for a late-breaking science session at the European Society of Cardiology�s ESC Congress 2019, Paris, August 31 � September 4, to present efficacy, tolerability and safety data from ORION-11. That abstract was accepted for presentation on Monday, September 2 at 9:22 am CET.

The Independent Data Monitoring Committee (IDMC) for inclisiran�s pivotal Phase III trials (ORION-9, ORION-10 and ORION-11) recently completed its seventh planned review of un-blinded safety and efficacy data. The committee again recommended that the trials continue without modification. Ongoing review of blinded data to date from the Phase III trials shows no material safety issues, and the emerging data are at least as favorable as those generated from the ORION-1 Phase II and the ORION-3 open label extension studies.

At the time of the seventh IDMC review, substantially all randomized patients in Phase III studies had been treated with four doses of inclisiran or placebo. More than 3,500 patient-years of inclisiran safety data have been accumulated in the ORION program, and additional safety data continues to accrue at a rate of five patient-years per day. Patients who have completed their respective Phase III studies are now enrolling into ORION-8, an open-label, long-term extension study where patients completing ORION-9, ORION-10 and ORION-11 will receive inclisiran for three years to evaluate the efficacy, safety and tolerability of long-term dosing of inclisiran.