- Amgen has licensed out an experimental heart disease drug, obicetrapib, to a newly formed biotech called NewAmsterdam Pharma. Terms weren't disclosed.
- Amgen first bought obicetrapib when it acquired Dutch biotech Dezima in 2015, but shelved the drug two years later. Some former Dezima founders — among them cardiovascular disease expert John Kastelein — have started NewAmsterdam and reacquired obicetrapib in an effort to revive the drug around a different clinical development plan. It's in talks with the Food and Drug Administration and European Medicines Agency about a Phase 3 program and aims to raise a "substantial" financing to back it by the end of the year.
- Obicetrapib is a CETP inhibitor, a class of drug once seen as a potentially big advance in cardiovascular medicine before the high-profile failures of multiple treatments. NewAmsterdam believes that obicetrapib has a chance to change the narrative, however, if tested in patients who don't respond to, or can't tolerate, statins — rather than alongside them as they were in the past.
It wasn't that long ago that CETP inhibitors were the next big thing in heart medicine.
The drugs were part of a bet by researchers that raising the levels of high-density lipoprotein (HDL), also known as "good" cholesterol, might be more effective than lowering low-density lipoprotein (LDL-C), or "bad" cholesterol.
Several large drugmakers, enticed by the potential of CETP inhibitors, raced to test the theory, only to see them fall short time and again. CETP blockers from Roche (dalcetrapib), Pfizer (torcetrapib) and Eli Lilly (evacetrapib) each failed large trials, and some of them led to serious side effects. Each were discarded by their developers, along with another from Merck & Co. that, while successful in a large trial, didn't have a "clinical profile" worth handing over to regulators. They were surpassed by LDL-lowering medicines like PCSK9 inhibitors, multiple of which have been approved by the FDA.
Amgen's obicetrapib was among those relegated to the pharmaceutical dustbin. It was originally developed by Dezima before Amgen scooped the company up in 2015 in a deal that was quickly met with significant skepticism, given the failures that had already occurred by then. Amgen, however, suspended the program a year later and tossed it aside shortly after Merck made its decision.
Yet CETP blockers live on, now in the hands of smaller biotechs. Dalcor picked up Roche's drug in 2015, and has spent years on a more precision approach, testing the drug in a genetic subset of heart disease patients. And now NewAmsterdam has emerged, breathing new life into Amgen's former program after Forbion — a Dezima co-founding investor — started talks to buy the drug back.
The startup represents a second crack at obicetrapib for Dezima scientific founder John Kastelein. NewAmsterdam aims to develop it for patients who either don't respond to cholesterol lowering statins or can't tolerate them because of side effects. Previous CETP blockers, such as those from Pfizer and Merck, were tested alongside cholesterol-lowering statins. An "observed interaction" between CETP inhibitors and high-dose statins was a "key lesson" from those trials, Kastelein said in a statement.
In an email to BioPharma Dive, CEO Michael Davidson wrote that Phase 2 testing of obicetrapib, the results of which were published in the Lancet in 2015, showed promise regarding "patient tolerance," as well as its ability to lower levels of Apolipoprotein B, a protein implicated in heart disease.
"Insights from the other CETP development programs have been helpful to us," CEO Michael Davidson wrote. "Our candidate seems to overcome all of the reasons that each of those programs had previously ended."
NewAmsterdam is currently discussing the outline of a Phase 3 program with regulators in the U.S. and Europe, as well as a large cardiovascular outcomes trial. Davidson, who in June sold Corvidia Therapeutics to Novo Nordisk for $725 million up front, declined to provide additional details on the startup's clinical development plan.
The company also wouldn't specify how much additional cash it is looking to raise, or what it paid Amgen to buy back the drug.