The Medicines Company Announces Recommendation by Independent Data Monitoring Committee to Continue Inclisiran Phase III Trials Following [Third] Review of Unblinded Data
–More than 1,550 patient-years of safety data accumulated to date – a three-fold increase over total patient exposure through Phase II trials–
–At the time of IDMC review, [substantially] all patients in Phase III trials had received two doses of inclisiran or placebo–
–Phase III trials of inclisiran progressing as planned with no material safety observations to date–
The Medicines Company (NASDAQ: MDCO) today announced that the Independent Data Monitoring Committee (IDMC) for the ongoing inclisiran Phase III trials has recommended that the trials continue as designed and conducted, without modification. The IDMC’s recommendation was based on its planned review of unblinded safety and efficacy data from the trials.
The ORION Phase III studies with 18-months 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 – its third since the ORION Phase III program began – [substantially] all randomized patients had been treated with two doses of inclisiran or placebo.
To date, more than 1,550 patient-years of safety data has been accumulated in the ORION Phase III program, a three-fold (or 1,000 patient-year) increase over the total patient exposure from the ORION Phase I and Phase II trials.
Commenting on the IDMC’s recommendation, David Kallend, Chief Medical Officer of The Medicines Company said, “We are highly encouraged by the IDMC’s clear recommendation, following its third review of unblinded data, from the ORION Phase III trials. We continue to advance the inclisiran Phase III program on a highly-efficient basis, with data readout expected in the second half of 2019.”
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 I clinical study, with The Medicines Company leading and funding the development of inclisiran from Phase II 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, regulatory submissions, product or indication launches, the Company’s strategy, future financial results and operations, 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 reports filed with the Securities and Exchange Commission (SEC) including, without limitation, the risk factors detailed in the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 9, 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.
Krishna Gorti, M.D., 973-290-6122
Vice President, Investor Relations