The Medicines Company Announces 5th Review of Un-blinded Data and Recommendation by Independent Data Monitoring Committee to Continue Inclisiran Phase 3 Trials
- 2019 is a momentous year for inclisiran, a first in class therapy with the potential to deliver potent, durable and consistent lowering of LDL-C levels via twice-a-year dosing.
- With full commercial rights in all geographies, The Medicines Company is well placed to harness the intrinsic value of inclisiran.
- No material safety observations to date as inclisiran enters final months of Phase 3 trials.
- To date, more than 2,450 patient-years of inclisiran safety data have been accumulated in the ORION program, a seven-fold (or 2,120 patient-year) increase over the total patient exposure from the ORION Phase 1 and Phase 2 trials.
- At the time of IDMC review, all patients in Phase 3 trials had received three doses of inclisiran or placebo.
- Fourth and final study dosing will be given within the next 6 months as countdown to Phase 3 results begins.
The Medicines Company (NASDAQ: MDCO) today announced that the 5th review of un-blinded safety and efficacy data by the Independent Data Monitoring Committee (IDMC) for inclisiran Phase 3 trials has been completed. The IDMC has once again recommended that the trials continue as designed and conducted, without modification.
“I am pleased and excited with the progress of the ORION program as we count down to pivotal Phase 3 results in the 3rd quarter. 2019 is a momentous year for inclisiran, a first in class therapy with the potential to deliver potent, durable and consistent lowering of LDL-C levels via twice-a-year dosing. The potential to address the world’s largest health problem and help patients around the world is enormous. With full commercial rights in all geographies, we are well placed to harness the intrinsic value of inclisiran,” said Mark Timney, Chief Executive Officer of The Medicines Company.
The ORION Phase 3 studies with 18-months treatment and follow-up were fully enrolled between November 2017 and March 2018, with 3,660 patients randomized 1:1 across three trials, ORION-9 (482 patients randomized), ORION-10 (1,561 patients randomized) and ORION-11 (1,617 patients randomized) to receive either inclisiran or placebo. At the time of the IDMC review, it’s 5th since the ORION Phase 3 program began, all randomized patients had been treated with three doses, and approximately 2,000 patients had completed a follow-up visit 60-days after the third dose of study medication. To date, more than 2,450 patient-years of inclisiran safety data have been accumulated in the ORION program, a seven-fold (or 2,120 patient-year) increase over the total patient exposure from the ORION Phase 1 and Phase 2 trials.
Commenting on the IDMC’s recommendation, David Kallend, Chief Medical Officer of The Medicines Company said, “Once again, we are highly encouraged by the IDMC’s clear recommendation, following its 5th review of unblinded data from the ORION Phase 3 trials. We continue to advance the inclisiran Phase 3 program on a highly-efficient basis, and now begin an exciting countdown as patients receive their fourth and final dose of study medication, and we progress to final data readout, as planned, in the second half of 2019.”
In the US alone, 67.5 million individuals are estimated to have sufficient cardiovascular risk to warrant lipid-lowering therapy. 27.5 million of these individuals are at a significantly elevated risk, either because of confirmed cardiovascular disease or LDL-C levels above 190 mg/dl. Of this higher risk group, 15.1 million are currently treated with lipid-lowering therapies, but only one out of five (or 2.4 million) is successfully reaching LDL-C targets with current therapies. This implies a population of at least 12.7 million Americans who could benefit from inclisiran, a first in class therapy with the potential to deliver potent, durable and consistent lowering of LDL-C levels via twice-a-year dosing.
Inclisiran is an investigational GalNAc-conjugated RNA interference therapeutic, which inhibits the synthesis of PCSK9 protein in liver cells, thereby reducing liver cell LDL-receptor turnover, and lowering plasma LDL-C.
The Medicines Company and Alnylam Pharmaceuticals, Inc. are collaborating in the advancement of inclisiran pursuant to their 2013 agreement. Under the terms of that agreement, Alnylam completed certain pre-clinical studies and the Phase 1 clinical study, with The Medicines Company leading and funding the development of inclisiran from Phase 2 forward, as well as potential commercialization.
About The Medicines Company
The Medicines Company is a biopharmaceutical company driven by an overriding purpose – to save lives, alleviate suffering and contribute to the economics of healthcare. The Company’s goal is to create transformational solutions to address the most pressing healthcare needs facing patients, physicians, and providers in cardiovascular care. The Company is headquartered in Parsippany, New Jersey.
Statements in this press release about The Medicines Company (the Company), the Company’s product candidate, inclisiran, the timing of clinical trial results, and future opportunities for the Company, that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words “believes," “anticipates," “plans,“ “expects," “intends," “estimates," “potential," “outlook,” “may,” “will,” “would,””could,” and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward looking statements, including: whether, inclisiran, will advance in the clinical trials process on a timely basis or at all; whether clinical trial results will warrant submission of applications for regulatory approval; whether inclisiran will receive approvals from regulatory agencies; the extent of the commercial success of inclisiran, if approved; and such other factors as are set forth in the risk factors detailed from time to time in the Company’s periodic and other reports and registration statements filed with the Securities and Exchange Commission (SEC) including, without limitation, the risk factors detailed in the Company’s Current Report on Form 8-K filed with the SEC on December 12, 2018, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements whether as a result of new information, future events or otherwise.
$MDCO Announces 5th Review of Un-blinded Data and Recommendation by Independent Data Monitoring Committee to Continue #Inclisiran Phase 3 Trials