The Medicines Company drops MDCO-216 as med comes up short

The Medicines Company ($MDCO) will stop all work on its anticholesterol candidate MDCO-216 several months after posting weak data that did not allow its test of the med to stop early.

The proof-of-concept study for this drug, the Milano-Pilot, was designed to test MDCO-216 to see if it could reduce atherosclerotic plaque burden and related CV events in 40 patients with coronary artery disease.

As preplanned, the New Jersey biotech allowed an Independent Data Monitoring Committee to look at its data and see whether it hit key efficacy targets, which would allow the trial to stop early--but in August, the biotech said its data were not strong enough to stop.

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At the time Clive Meanwell, CEO of The Medicines Company, said that “the study is continuing and we look forward to receiving full access to the final data,” but after hours last night, on the eve of the U.S. election, the biotech said it was now ditching work on the drug.

“Data from the recently-completed Milano-Pilot trial did not show drug effects on intracoronary atherosclerotic plaque sufficient to warrant further development,” the company said in a statement.

It said it will now refocus its R&D energy into its PCSK9 synthesis inhibitor candidate, which recently saw some positive data coming out of the Orion-1 test.

The early success for this midstage med also “drove the company’s decision to discontinue further investment in the clinical development of MDCO-216,” given that this “will free up substantial additional capital” to throw at its other candidate.  

Meanwell said: “We deliberately focused our initial development investment in MDCO-216 on clinical proof of concept. Unfortunately, the efficacy data from Milano-Pilot do not support a prudent decision to make the significant, near-term investment required to move MDCO-216 forward.”

MDCO-216 mimics pre-beta HDL and induces cholesterol efflux, which is the first step in the reverse cholesterol transport, a process of removal of deposited cholesterol from vessel walls, and was believed to have the potential to reduce plaque burden in patients with coronary artery disease.

Meanwell went on: “In spite of promising earlier research findings, and impressive progress with manufacturing development and safety, in the light of these efficacy data and in view of the potentially enormous opportunity and highly-favorable risk-reward profile presented by our PSCK9 synthesis inhibitor, we have been decisive in immediately terminating the MDCO-216 development program. This decision will allow us to reallocate substantial additional capital to the further development of our PCSK9 synthesis inhibitor.”

The biotech hopes this drug will beat out other PCSK9 rivals from Sanofi ($SNY) and Regeneron ($REGN), as well as Amgen ($AMGN).

But recent R&D has not been great here too, with Pfizer ($PFE) announcing last week its shock decision to drop all work on its PCSK9 inhibitor bococizumab after finding “no value” in the drug.

The biotech was down 6% at the end of August when the first bad news broke--and after hours last night it was again down by 6%, with a market cap of $2.2 billion.

But The Medicines Company did say that it didn’t expect to be hit by any charges from the discontinuation of MDCO-216.

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