Obicetrapib, first CETP inhibitor, approved for high cholesterol treatment.

NewAmsterdam Pharma's obicetrapib, an inhibitor of cholesteryl ester transfer protein (CETP), is set to be the first available CETP inhibitor as a dietary supplement for patients with primary hypercholesterolemia or mixed dyslipidemia who cannot achieve LDL cholesterol target levels on maximum tolerated statin doses or who are statin intolerant or contraindicated. Obicetrapib has shown significant efficacy in Phase III trials BROOKLYN and BROADWAY, and in the TANDEM trial, it demonstrated a statistically significant difference in efficacy compared to placebo when combined with lipid-lowering therapies at maximum tolerated doses.

NewAmsterdam Pharma has made significant strides in its effort to develop obicetrapib as the first available CETP inhibitor in dietary supplement form. The company's obicetrapib has shown promising results in Phase III trials, indicating its potential to help patients with primary hypercholesterolemia or mixed dyslipidemia who cannot achieve their LDL cholesterol targets on maximum tolerated statin doses or who are statin intolerant or contraindicated.

In the BROOKLYN and BROADWAY trials, obicetrapib demonstrated significant efficacy, reducing LDL cholesterol levels by approximately 15% compared to placebo. Furthermore, in the TANDEM trial, obicetrapib showed a statistically significant difference in efficacy compared to placebo when combined with lipid-lowering therapies at maximum tolerated doses, reducing LDL cholesterol levels by an average of 21% [1].

The development of obicetrapib is particularly notable because it represents a novel approach to managing cholesterol levels. CETP inhibitors work by inhibiting the enzyme cholesteryl ester transfer protein (CETP), which is responsible for transferring cholesterol from HDL (good cholesterol) to LDL (bad cholesterol). By reducing CETP activity, obicetrapib can help lower LDL cholesterol levels more effectively than statins alone.

The success of obicetrapib in clinical trials suggests that it could offer an alternative treatment option for patients who are unable to tolerate or respond to statins. This is particularly important given that nearly 70% of people with ASCVD who are treated with lipid-lowering therapies do not reach their target LDL cholesterol levels [2].

NewAmsterdam Pharma's focus on developing obicetrapib aligns with the broader trend in the pharmaceutical industry to explore new approaches to managing cardiovascular disease. Merck, for example, has been at the forefront of developing innovative treatments for hypercholesterolemia, with its oral PCSK9 inhibitor enlicitide decanoate showing promising results in Phase 3 trials [3].

The potential of obicetrapib as a dietary supplement could revolutionize the way cholesterol management is approached. If approved, it could provide patients with a convenient and effective way to manage their cholesterol levels, potentially reducing the risk of ASCVD events such as heart attacks and strokes.

References:

[1] https://www.marketscreener.com/news/alnylam-pharmaceuticals-insider-sold-shares-worth-1-557-649-according-to-a-recent-sec-filing-ce7d59dad88ff123
[2] https://www.pharmalive.com/mercks-cholesterol-drug-gets-a-boost-with-another-late-stage-trial-success/
[3] https://www.morningstar.com/news/business-wire/20250902024418/mercks-investigational-oral-pcsk9-inhibitor-enlicitide-decanoate-met-all-primary-and-key-secondary-endpoints-in-adults-with-hypercholesterolemia-in-pivotal-coralreef-lipids-study