Orion-1 at ACC.17: Stellar Results Could Make Inclisiran the New PCSK9 Star


A lot of the hype surrounding ACC.17 is due to the release of cardiovascular (CV) outcomes data for Repatha (evolocumab), Amgen’s PCSK9 inhibitor. As interesting and as important as these data will be, the results of another trial will highlight the potential of what could be the next generation of LDL-cholesterol-lowering medications.

In November, The Medicines Company and Alnylam Pharmaceuticals announced positive results from the Phase II ORION-1 trial. On the afternoon of Friday March 17, following the presentation of the FOURIER outcomes data that morning, we get to see the details. ORION-1 investigated the safety and efficacy of a single dose of inclisiran, the companies’ long-acting drug candidate that inhibits PCSK9 through RNA interference. Not only does inclisiran act via a different mechanism than the currently available PCSK9 inhibitors, it might only need to be administered every 6 months or possibly even less frequently. Hopefully, the full data read out will support Phase III development and encourage the likelihood of CV benefits with inclisiran.

With many people who have high LDL-cholesterol levels having multiple comorbidities, a drug that might only require administration once or twice a year would be highly desirable. Not only would such an agent be highly convenient for patients, it would be welcomed by clinicians who could ensure compliance by administering the treatment at routine check-ups. The Medicines Company and Alnylam might have a therapy that can bridge the gap until vaccinations for reducing LDL-cholesterol levels and CV risk become a reality.

Statins have long been the star of the show for hypercholesterolemia, and the astronomical efficacy of the PCSK9 inhibitors have seen these agents shoot up in experts’ estimations (if not in sales), but inclisiran may open up a whole new therapeutic universe.

For an overview of some of the other exciting new research on dyslipidemia treatments being presented at ACC.17, please click here.

For DRG’s analysis of the Dyslipidemia market, please click here.