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However, Dr Kastelein argues that much of the past disappointment can be put down to mistakes made with the class’s development. Given CETP inhibition’s history, approval ahead of outcomes data cannot be assumed. Prevail should follow with data in early 2026. The former is primarily measuring LDL and should read out early in 2024. The Broadway and Prevail trials are intended to confirm this in substantially more patients.
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The completed phase 2b Rose trial found a 51% reduction in LDL cholesterol in obicetrapib-treated patients already on high-intensity statin therapy – a result that makes the CETP inhibitor “just as potent” as Novartis’s PCSK9 drug Leqvio, he says. We don't want to end up with prior authorisations, paperwork, and people that hate us because they think we're greedy.”įirst obicetrapib needs to prove itself in the clinic, and Mr Kastelein believes that the project will be as effective as PCSK9s.
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“30 million people in Europe, the US and Japan need additional LDL lowering. “We will have a drug priced according to the health economic benefits it gives,” he says. This is where New Amsterdam sees obicetrapib coming in. The high price of PCSK9s means that they are not used as widely as they should be, Dr Kastelein maintains. Success would put the project on a similar footing to mechanisms including PCSK9 inhibitors, which are known to be very effective at lowering LDL.Ĭheap statins are always the first option when cholesterol needs lowering, but many people fail to get as low as advised. The clinical programme under way is designed to win approval for obicetrapib in a secondary prevention setting – to reduce the risk of heart attacks or strokes in people with established cardiovascular disease. Dr Kastelein estimates that Prevail, a cardiovascular outcome study seeking 9,000 subjects, will cost $150-200m, but declined to say how funds might be raised.
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The series A was only done in January 2021, led by the venture firms Ascendant BioCapital and Morningside, but more cash will be needed to complete two large clinical studies. “There was an enormous enthusiasm to develop this drug from a financial and business point of view,” says the company’s founder and chief scientific officer, John Kastelein, telling Evaluate Vantage that a second funding round was already in the works. With them died the HDL hypothesis: that heart attacks and strokes could be prevented by hiking levels of so-called “good” cholesterol.Īrmed with a $200m series A round and Amgen’s unwanted CETP inhibitor obicetrapib, New Amsterdam is embarking on a revival of the mechanism, but this time focusing on LDL reduction. The failure of CETP inhibitors to prove themselves as a treatment for cardiovascular disease must rank as one of the biggest, and costliest, R&D disappointments of the past 20 years.