Dive Brief:
- 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.
Dive Insight:
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.