MedCo holds out for full analysis of cholesterol data
- The Medicine Company’s MDCO-216, a complex of an apolipoprotein and a phospholipid, is in development for patients with acute coronary syndrome.
- An interim analysis of a Phase I/II study of MDCO-216, MILANO-PILOT, has come up as ‘inconclusive’ in the first 40 patients; the company is waiting for 120-patient data before it pushes forward into Phase III trials.
- Enrollment of the 120 patients is complete, and data will be presented at the American Heart Association Scientific Sessions 2016 on 15 November 2016 in New Orleans.
According to Clive Meanwell, the Medicines Company CEO, “the data are inconclusive,” and so the study continues.
According to analysts at Jefferies, if the results at the AHA show a decrease in percentage atheroma volume of 1% or more at week 5, the Phase 3 trial could be a go. The analysts add that The Medicine Company’s shares could be under a degree of pressure based on this inconclusive outcome.
Also at the AHA will be the interim analysis of data from the ORION-1 Phase 2 study of The Medicines Company’s second hyperlipidemia drug, PCSK9si. This is an RNAi therapeutic that uses a delivery platform licensed from Alnylam, and positive results could also mean the start of another Phase 3 trial.
The Medicines Company was rumored to be thinking about a trade sale in January 2016, but seemed to change its mind when it sold off a number of cardiovascular drugs to Chiesi Farmaceutici in a deal worth almost $800 million in May 2016. This left it with a more focused cardiovascular pipeline of just two candidates that focus on dyslipidemia, both in clinical trials. While it’s a competitive market, according to IMS, lipid regulators were the 12th-ranked global market in 2015, at a value of $26.6 billion, making it a market to watch.
- The Medicines Company Statement
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