The Medicines Company (MDCO) announced that the Independent Data Monitoring Committee (IDMC) for the ongoing inclisiran Phase III trials recommended that the studies continue uninterrupted and without modification, notes John McCamant, editor of The Medical Technology Stock Letter.

The IDMC’s recommendation was based on its planned review of un-blinded 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.

This is the third IDMC review since the ORION Phase III program began and substantially all randomized patients had been treated with two doses of inclisiran or placebo.

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-years) increase over the total patient exposure from the ORION Phase I and Phase II trials.

Also, during an oral presentation at American Diabetes Association annual meeting (ADA 2018) the company presented data showing that a subcutaneous injection of 300 mg of inclisiran given at Day-1 and Day-90 lowered LDL-cholesterol (LDL-C) at Day-180 by more than 50% in patients with atherosclerotic cardiovascular disease (ASCVD) and those considered ASCVD-risk equivalents, regardless of whether those patients had diabetes.

Inclisiran demonstrated a similar adverse event profile in patients with and without diabetes, including no effects on control of blood glucose levels over six months.

The data presented at ADA 2018 further confirm the robust and consistent efficacy of inclisiran on atherogenic lipoproteins across multiple patient populations, irrespective of their diabetes status.

The continued excellent safety profile with over 1,500 patient years of safety has further de-risked the Phase III data readouts expected in H2:19, and in our view, also makes the Phase III outcomes trial an even lower risk endeavor. We continue to believe that Inclisiran is one of the most undervalued Phase III assets with blockbuster potential in the drug industry.

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