NewAmsterdam Pharma has completed the enrolment of 407 patients in the pivotal Phase III TANDEM clinical trial evaluating obicetrapib in combination with ezetimibe in patients with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD). Obicetrapib has demonstrated strong tolerability in more than 800 patients with elevated lipid levels in NewAmsterdam’s clinical trials to date. Hence, obicetrapib has the potential to become the first cholesteryl ester transfer protein (CETP) inhibitor to advance to clinical practice.
CETP inhibitors increase high-density lipoprotein (HDL) cholesterol and decrease triglyceride levels by inhibiting the transfer of cholesteryl esters from HDL to apolipoprotein B-containing lipoproteins. CETP inhibitors have been found to reduce Lp(a) levels by inhibiting the transfer of cholesterol esters from HDL to apo(a)-containing lipoprotein. This results in a decrease in the formation of Lp(a) particles in the blood.
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NewAmsterdam has shown promising data in all Phase II trials, ROSE2, TULIP, ROSE, and OCEAN, evaluating obicetrapib as a monotherapy or combination therapy, with the ability of obicetrapib to statistically reduce low-density lipoprotein (LDL). The completion of the Phase III TANDEM trial enrollment is a step towards the potential launch of obicetrapib, bringing NewAmsterdam closer to providing a new treatment option for HeFH and/or ASCVD. If successful, the results from the TANDEM trial could lead to a new treatment option for patients struggling with high cholesterol, particularly those who do not respond to current therapies. NewAmsterdam’s obicetrapib is expected to be the most promising agent to launch in the dyslipidemia market by 2032. GlobalData also forecasts that the largest pipeline drug sales in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) will come from obicetrapib, with an estimated $1.40bn in sales by 2032.
While there is currently an unmet need for therapies that specifically target Lp(a), there are promising approaches in development that may fill this gap and provide new treatment options for dyslipidemia and cardiovascular disease. The potential launch of CETP inhibitors will partially fulfil this unmet need. However, it is clear that there is ample opportunity for a specific Lp(a)-targeting therapy to enter the market, particularly for the treatment of high-risk patients.
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